Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000156-28 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel. Participants in both cohorts will subsequently undergo surgical treatment and then resume pertuzumab and trastuzumab treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | Experimental | Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams [mg] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram [mg/kg] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
|
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Experimental | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-Fluorouracil | Drug | Participants will receive 5-fluorouracil 500 mg/m^2 IV on Day 1 of each cycle q3w. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Neoadjuvant Treatment Period | Symptomatic left ventricular systolic dysfunction (otherwise referred to as heart failure) is a serious adverse event. The NYHA Functional Classification System for Heart Failure considers the patient's symptoms: Class III: Marked limitation of physical activity; Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort; Symptoms of heart failure at rest; If any physical activity is undertaken, discomfort increases. The 95% CIs were calculated with the Clopper-Pearson method. Results included events with onset from first dose of pertuzumab/trastuzumab prior to surgery through the day before the first dose of any study drug after surgery. If participant withdrew without entering adjuvant period, results included all events with onset from first dose of pertuzumab/trastuzumab through 42 days after last dose of any study drug or on the day of target surgery whichever was later. | From day of first dose of pertuzumab or trastuzumab until the end of the neoadjuvant treatment period (as defined in the description; up to 25 weeks) |
| Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Neoadjuvant Treatment Period | LVEF significant decline was defined as the decline in LVEF of >/= 10%-points from baseline to an LVEF of < 50%. A Confirmed LVEF Significant Decline was defined as at least two consecutive readings of significant declines in LVEF. A Single LVEF Significant Decline was defined as only one reading of a significant decline (no consecutive readings) in LVEF. The category of 'At Least one LVEF Significant Decline Event' was defined as the total of confirmed and single LVEF significant declines. The 95% confidence intervals (CIs) were calculated using the Clopper-Pearson method. Results include events with onset from the first dose of pertuzumab or trastuzumab prior to surgery through the day before the first dose of any study drug after surgery. If participant withdrew without entering adjuvant period, results included all events with onset from first dose of pertuzumab or trastuzumab through 42 days after last dose of any study drug or on the day of target surgery whichever is later. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Adjuvant Treatment Period | Symptomatic left ventricular systolic dysfunction (otherwise referred to as heart failure) is a serious adverse event. The NYHA Functional Classification System for Heart Failure considers the patient's symptoms: Class III: Marked limitation of physical activity; Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort; Symptoms of heart failure at rest; If any physical activity is undertaken, discomfort increases. The 95% CIs were calculated with the Clopper-Pearson method. Results included events with onset from the first dose of any study drug after surgery through 42 days after the last dose of any study drug. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama; Mitchell Cancer Institute | Mobile | Alabama | 36604 | United States | ||
| Marin Specialty Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29253081 | Derived | Swain SM, Ewer MS, Viale G, Delaloge S, Ferrero JM, Verrill M, Colomer R, Vieira C, Werner TL, Douthwaite H, Bradley D, Waldron-Lynch M, Kiermaier A, Eng-Wong J, Dang C; BERENICE Study Group. Pertuzumab, trastuzumab, and standard anthracycline- and taxane-based chemotherapy for the neoadjuvant treatment of patients with HER2-positive localized breast cancer (BERENICE): a phase II, open-label, multicenter, multinational cardiac safety study. Ann Oncol. 2018 Mar 1;29(3):646-653. doi: 10.1093/annonc/mdx773. |
Not provided
Not provided
A total of 401 participants were enrolled, 199 in Cohort A and 202 in Cohort B. One participant in Cohort B who was human epidermal growth factor receptor 2 (HER2) negative and was enrolled by error, was excluded. Hence, 199 participants were included in Cohort A and 201 participants in Cohort B.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams [mg] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram [mg/kg] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cyclophosphamide | Drug | Participants will receive cyclophosphamide 600 milligrams per square meter (mg/m^2) intravenous (IV) given on Day 1 of each cycle q2w. |
|
| Docetaxel | Drug | Participants will receive docetaxel at a starting dose of 75 mg/m^2 IV for the first cycle and the dose may be escalated to 100 mg/m^2 for subsequent cycles q3w. |
|
| Doxorubicin | Drug | Participants will receive doxorubicin 60 mg/m^2 IV on Day 1 of each cycle q2w. |
|
| Epirubicin | Drug | Participants will receive epirubicin 100 mg/m^2 IV on Day 1 of each cycle q3w. |
|
| Paclitaxel | Drug | Participants will receive paclitaxel 80 mg/m^2 IV given weekly. |
|
| Pertuzumab | Drug | Participants will receive pertuzumab at a loading dose of 840 milligrams (mg) IV loading dose, then 420 mg IV q3w. |
|
|
| Trastuzumab | Drug | Participants will receive trastuzumab at a loading dose of 8 milligrams per kilogram (mg/kg) IV, then 6 mg/kg IV q3w. |
|
|
| From day of first dose of pertuzumab or trastuzumab until the end of the neoadjuvant treatment period (as defined in the description; up to 25 weeks) |
| From the first dose of any study drug after surgery through 42 days after the last dose of any study drug (during the adjuvant treatment period; up to approximately 39 weeks) |
| Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Adjuvant Treatment Period | LVEF significant decline was defined as the decline in LVEF of >/= 10%-points from baseline to an LVEF of < 50%. A Confirmed LVEF Significant Decline was defined as at least two consecutive readings of significant declines in LVEF. A Single LVEF Significant Decline was defined as only one reading of a significant decline (no consecutive readings) in LVEF. The category of 'At Least one LVEF Significant Decline Event' was defined as the total of confirmed and single LVEF significant declines. The 95% confidence intervals were calculated using the Clopper-Pearson method. Results included events with onset from the first dose of any study drug after surgery through 42 days after the last dose of any study drug. | From the first dose of any study drug after surgery through 42 days after the last dose of any study drug (during the adjuvant treatment period; up to approximately 39 weeks) |
| Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Treatment-Free Follow-Up Period | Symptomatic left ventricular systolic dysfunction (otherwise referred to as heart failure) is a serious adverse event. The NYHA Functional Classification System for Heart Failure considers the patient's symptoms: Class III: Marked limitation of physical activity; Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort; Symptoms of heart failure at rest; If any physical activity is undertaken, discomfort increases. The 95% CIs were calculated with the Clopper-Pearson method. | From 42 days after the last dose of study treatment until the end of treatment-free follow-up (up to 5 years) |
| Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Treatment-Free Follow-Up Period | LVEF significant decline was defined as the decline in LVEF of >/= 10%-points from baseline to an LVEF of < 50%. A Confirmed LVEF Significant Decline was defined as at least two consecutive readings of significant declines in LVEF. A Single LVEF Significant Decline was defined as only one reading of a significant decline (no consecutive readings) in LVEF. The category of 'At Least one LVEF Significant Decline Event' was defined as the total of confirmed and single LVEF significant declines. The 95% confidence intervals were calculated using the Clopper-Pearson method. | From 42 days after the last dose of study treatment until the end of treatment-free follow-up (up to 5 years) |
| Overview of the Number of Participants With at Least One Adverse Event During the Neoadjuvant Period | An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The terms "severe" and "serious" are not synonymous with respect to an AE. Severity refers to the intensity of an AE (rated according to NCI-CTCAE v4.0 criteria or, if not listed, the following scale: Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), whereas a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness needed to be independently assessed for each AE that was recorded. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as an AE with the term of ejection fraction decreased). In the results table, multiple occurrences of the same AE in one individual were counted only once. Any AE includes all serious and non-serious AEs. | From first dose of any study drug prior to surgery through the day before the first dose of study drug after surgery (up to 25 weeks) |
| Overview of the Number of Participants With at Least One Adverse Event During the Adjuvant Period | An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The terms "severe" and "serious" are not synonymous with respect to an AE. Severity refers to the intensity of an AE (rated according to NCI-CTCAE v4.0 criteria or, if not listed, the following scale: Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), whereas a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness needed to be independently assessed for each AE that was recorded. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as an AE with the term of ejection fraction decreased). In the results table, multiple occurrences of the same AE in one individual were counted only once. Any AE includes all serious and non-serious AEs. | From the first dose of any study drug after surgery through 42 days after the last dose of any study drug (during the adjuvant treatment period; up to approximately 39 weeks) |
| Overview of the Number of Participants With at Least One Adverse Event During the Treatment-Free Follow-Up Period | An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The terms "severe" and "serious" are not synonymous. Severity refers to the intensity of an AE (rated according to NCI-CTCAE v4.0 criteria or, if not listed, the following scale: Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), and a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness were independently assessed for each AE. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as ejection fraction decreased). During TFFU, only heart failure, pregnancies, and non-breast-related second primary malignancies, irrespective of causal relationship with study treatment, and drug-related SAEs were reported. Multiple occurrences of the same AE in 1 subject were counted only once. | From 42 days after the last dose of study treatment until the end of treatment-free follow-up (TFFU; up to 5 years) |
| Percentage of Participants Positive for Anti-Therapeutic Antibodies (ATAs) to Pertuzumab at Baseline and Anytime Post-Baseline | ATAs to pertuzumab in serum samples were detected using a validated bridging enzyme-linked immunosorbent assay (ELISA) method. This analysis only included participants with an ATA assay result from a baseline sample and/or at least one post-baseline sample. | Screening (baseline) then prior to pertuzumab infusion (Hour 0) in Cycles 5, 14, 18 thereafter anytime between Cycle 8 Day 21 and surgery, up to treatment completion visit (cycle length=2-3 weeks; up to approximately 1 year, 3 months) |
| Percentage of Participants With Total Pathologic Complete Response (tpCR), Evaluated After Surgery | Total pathologic complete response (tpCR) was the pCR based on tumor and nodal staging (i.e., histological confirmation of pCR in breast and nodes at surgery) and was defined as the absence of any residual invasive cancer in the breast and the absence of any metastatic cells in the regional lymph nodes (i.e., ypT0/is ypN0 tpCR). Participants who did not undergo surgery or did not have a valid pCR assessment were considered non-responders in the analysis. The 95% CIs were calculated using the Clopper-Pearson method. | After completion of neoadjuvant treatment and surgery (up to 25 weeks) |
| Percentage of Participants With Clinical Response as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 During the Neoadjuvant Treatment Period | The clinical response rate was defined as the percentage of participants in the ITT population who achieved a complete response (CR) or partial response (PR) prior to surgery, according to RECIST v1.1. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter compared to Baseline. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Progressive Disease (PD): at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. Participants were classified as missing or unevaluable if no assessments were measured prior to surgery on the ipsilateral breast. The 95% CIs were calculated using the Clopper-Pearson method; they were only calculated for responses (not for missing or unevaluable data). | From Baseline until disease progression or death due to any cause up to 24 weeks (during the neoadjuvant treatment period; assessed on Day 1 of Cycles 1-8 [cycle length=2-3 weeks]) |
| Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Event-Free Survival (EFS) at 1 to 5 Years, Determined by the Investigator According to RECIST v1.1 | The Kaplan-Meier method was used to estimate the percentage of participants who were event-free at landmark timepoints. Event-free survival (EFS) was defined as the time from enrollment to the first occurrence of progressive disease (PD), relapse, or death from any cause, with tumor evaluations performed by the investigator according to RECIST v1.1. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) were not counted as progressive disease or relapse. Participants who withdrew from the study without documented progression or relapse and for whom there existed evidence that evaluations had been made, were censored at the date of the last assessment at which the participant was known to be free from progressive disease or relapse. Participants with no tumor evaluations after baseline were censored at the date of enrollment plus 1 day. | At 1, 2, 3, 4, and 5 years |
| Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Invasive Disease-Free Survival (iDFS) at 1 to 4 Years, Determined by the Investigator According to RECIST v1.1 | The Kaplan-Meier method was used to estimate the percentage of participants who were event-free at landmark timepoints. Invasive disease-free survival (iDFS) was defined as the time from the first date of no disease (the date of surgery) to the first documentation of progressive invasive disease, relapse, or death, with tumor evaluations performed by the investigator according to RECIST v1.1. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) were not counted as progressive disease or relapse. Participants who withdrew from the study without documented progression or relapse and for whom there existed evidence that evaluations had been made, were censored at the date of the last assessment at which the participant was known to be alive and disease-free. Participants with no postbaseline information and participants who did not undergo surgery were excluded from the analysis. | At 1, 2, 3, and 4 years |
| Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Overall Survival (OS) at 1 to 5 Years | The Kaplan-Meier method was used to estimate the percentage of participants who were event-free at landmark timepoints. Overall survival (OS) was defined as the time from enrollment to death from any cause. Participants who were alive or lost to follow-up were censored at their last known date in the study. Participants with no post-baseline assessments were censored at the date of enrollment plus 1 day. | At 1, 2, 3, 4, and 5 years |
| Greenbrae |
| California |
| 94904 |
| United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center) | Washington D.C. | District of Columbia | 20007 | United States |
| Washington Cancer Institute at MedStar Washington Hospital Center. | Washington D.C. | District of Columbia | 20010 | United States |
| Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) | Jacksonville | Florida | 32256 | United States |
| Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | 30060 | United States |
| Berkshire Medical Center | Pittsfield | Massachusetts | 01201 | United States |
| Allina Health, Virginia Piper Cancer Institute | Minneapolis | Minnesota | 55407 | United States |
| Saint Lukes Hospital Cancer Institute | Kansas City | Missouri | 64111 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Regional Cancer Care Associates LLC - Morristown | Morristown | New Jersey | 07962 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| MSKCC @ Commack | Commack | New York | 11725 | United States |
| MSKCC @ West Harrison | Harrison | New York | 10604 | United States |
| Mount Sinai Beth Israel Comprehensive Cancer Center | New York | New York | 10011 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| MSKC @ Rockville | Rockville Centre | New York | 11570 | United States |
| Mercy Clinic Oklahoma Communties, Inc | Oklahoma City | Oklahoma | 73120 | United States |
| Harrington Cancer Center | Amarillo | Texas | 79106 | United States |
| University of Utah; Huntsman Cancer Hospital | Salt Lake City | Utah | 84112 | United States |
| Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | United States |
| PeaceHealth St. Joseph Cancer Center | Bellingham | Washington | 98225 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
| Horizon Health Network | Moncton | New Brunswick | E1C 6Z8 | Canada |
| Royal Victoria Hospital | Barrie | Ontario | L4M 6M2 | Canada |
| Cite de La Sante de Laval; Hemato-Oncologie | Laval | Quebec | H7M 3L9 | Canada |
| St Mary's Hospital Center | Montreal | Quebec | H3T1M5 | Canada |
| Hopital Sacre-Coeur Research Centre | Montreal | Quebec | H4J 1C5 | Canada |
| Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| Herlev Hospital; Afdeling for Kræftbehandling | Herlev | 2730 | Denmark |
| Rigshospitalet; Onkologisk Klinik | København Ø | 2100 | Denmark |
| Vejle Sygehus; Onkologisk Afdeling | Vejle | 7100 | Denmark |
| Clinique Victor Hugo; Chimiotherapie | Le Mans | 72015 | France |
| Centre Oscar Lambret; Cancerologie Gynecologique | Lille | 59020 | France |
| Centre Leon Berard; Departement Oncologie Medicale | Lyon | 69373 | France |
| Clinique Clementville; Hopital De Jour | Montpellier | 34070 | France |
| Centre D'Oncologie de Gentilly; Oncology | Nancy | 54100 | France |
| Centre Antoine Lacassagne; Hopital De Jour A2 | Nice | 06189 | France |
| Institut Curie; Oncologie Medicale | Paris | 75231 | France |
| Centre Eugene Marquis; Unite Huguenin | Rennes | 35042 | France |
| Institut Gustave Roussy; Departement Oncologie Medicale | Villejuif | 94805 | France |
| Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe | Dresden | 01307 | Germany |
| Dres.Andreas Ammon und Dirk Meyer | Göttingen | 37073 | Germany |
| Dres. Andreas Köhler und Roswitha Fuchs | Langen | 63225 | Germany |
| Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde | München | 81675 | Germany |
| Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe | Neuruppin | 16816 | Germany |
| Asl Le-Ospedale "Vito Fazzi";U.O. Oncologia | Lecce | Apulia | 73100 | Italy |
| Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche | Rome | Lazio | 00161 | Italy |
| A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica | Turin | Piedmont | 10126 | Italy |
| Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello | Palermo | Sicily | 90146 | Italy |
| Ospedale Santa Maria Annunziata; Oncologia | Bagno a Ripoli | Tuscany | 50012 | Italy |
| Ospedale Della Misericordia; U.O. Di Medicina Ia - Oncologia Medica | Grosseto | Tuscany | 58100 | Italy |
| Iem-Fucam | D.F. | 04980 | Mexico |
| Centro de Diagnóstico y Tratamiento Integral de Mama, Hospital San José Tec de Monterrey | Monterrey | 64710 | Mexico |
| Haukeland Universitetssjukehus; Klinisk forskningspost | Bergen | 5021 | Norway |
| Oslo universitetssykehus HF, Ullevål, Kreftsenteret | Oslo | 0450 | Norway |
| Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej | Bialystok | 15-027 | Poland |
| Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii | Krakow | 30-688 | Poland |
| Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii | Otwock | 05-400 | Poland |
| Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie | Poznan | 61-866 | Poland |
| Centro Clinico Champalimaud; Oncologia Medica | Lisbon | 1400-038 | Portugal |
| Hospital de Santa Maria; Servico de Oncologia Medica | Lisbon | 1649-035 | Portugal |
| Hospital Beatriz Angelo; Departamento de Oncologia | Loures | 2674-514 | Portugal |
| IPO do Porto; Servico de Oncologia Medica | Porto | 4200-072 | Portugal |
| Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario Reina Sofia; Servicio de Oncologia | Córdoba | Cordoba | 14004 | Spain |
| Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia | A Coruña | 15009 | Spain |
| Hospital Universitario de la Princesa; Servicio de Oncologia | Madrid | 28006 | Spain |
| Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | 28034 | Spain |
| Hospital Universitario Virgen Macarena; Servicio de Oncologia | Seville | 41009 | Spain |
| Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia | Toledo | 45004 | Spain |
| Royal United Hospital; Oncology Department | Bath | BA1 3NG | United Kingdom |
| Royal Bournemouth Hospital; Oncology | Bournemouth | BH7 7DW | United Kingdom |
| Guys & St Thomas Hospital; Department of Oncology | London | SE1 9RT | United Kingdom |
| Royal Marsden Hospital - Fulham; Oncology Department | London | SW3 6JJ | United Kingdom |
| Freeman Hospital; Northern Centre For Cancer Care | New Castle Upon Tyne | NE7 7DN | United Kingdom |
| Churchill Hospital; Oxford Cancer and Haematology Centre | Oxford | OX3 7LJ | United Kingdom |
| Peterborough City Hospital, Edith Cavell Campus; Oncology Department | Peterborough | PE3 9GZ | United Kingdom |
| Royal Marsden Hospital; Dept of Medical Oncology | Sutton | SM2 5PT | United Kingdom |
| FG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
|
| Received Any Cohort A Study Treatment | Safety Population for Cohort A |
|
| Received Any Cohort B Study Treatment | Safety Population for Cohort B |
|
| Underwent Surgery |
|
| Completed Neoadjuvant Treatment (25 Weeks) |
|
| Started Adjuvant Treatment |
|
| Completed Adjuvant Treatment (Up to 39 Weeks) |
|
| Started Treatment-Free Follow-Up (Up to 5 Years) | Includes participants who completed or discontinued neoadjuvant/adjuvant treatment. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to treat (ITT) population included all participants who were enrolled regardless of whether they received any study treatment. One participant in Cohort B who was HER2 negative and was enrolled by error was excluded from the ITT population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams [mg] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram [mg/kg] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
| BG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Neoadjuvant Treatment Period | Symptomatic left ventricular systolic dysfunction (otherwise referred to as heart failure) is a serious adverse event. The NYHA Functional Classification System for Heart Failure considers the patient's symptoms: Class III: Marked limitation of physical activity; Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort; Symptoms of heart failure at rest; If any physical activity is undertaken, discomfort increases. The 95% CIs were calculated with the Clopper-Pearson method. Results included events with onset from first dose of pertuzumab/trastuzumab prior to surgery through the day before the first dose of any study drug after surgery. If participant withdrew without entering adjuvant period, results included all events with onset from first dose of pertuzumab/trastuzumab through 42 days after last dose of any study drug or on the day of target surgery whichever was later. | Safety analysis population of all participants who received any study treatment during the neoadjuvant treatment period, grouped according to treatment received. | Posted | Number | 95% Confidence Interval | percentage of participants | From day of first dose of pertuzumab or trastuzumab until the end of the neoadjuvant treatment period (as defined in the description; up to 25 weeks) |
|
|
| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Neoadjuvant Treatment Period | LVEF significant decline was defined as the decline in LVEF of >/= 10%-points from baseline to an LVEF of < 50%. A Confirmed LVEF Significant Decline was defined as at least two consecutive readings of significant declines in LVEF. A Single LVEF Significant Decline was defined as only one reading of a significant decline (no consecutive readings) in LVEF. The category of 'At Least one LVEF Significant Decline Event' was defined as the total of confirmed and single LVEF significant declines. The 95% confidence intervals (CIs) were calculated using the Clopper-Pearson method. Results include events with onset from the first dose of pertuzumab or trastuzumab prior to surgery through the day before the first dose of any study drug after surgery. If participant withdrew without entering adjuvant period, results included all events with onset from first dose of pertuzumab or trastuzumab through 42 days after last dose of any study drug or on the day of target surgery whichever is later. | Safety analysis population of all participants who received any study treatment during the neoadjuvant treatment period, grouped according to treatment received. | Posted | Number | 95% Confidence Interval | percentage of participants | From day of first dose of pertuzumab or trastuzumab until the end of the neoadjuvant treatment period (as defined in the description; up to 25 weeks) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Adjuvant Treatment Period | Symptomatic left ventricular systolic dysfunction (otherwise referred to as heart failure) is a serious adverse event. The NYHA Functional Classification System for Heart Failure considers the patient's symptoms: Class III: Marked limitation of physical activity; Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort; Symptoms of heart failure at rest; If any physical activity is undertaken, discomfort increases. The 95% CIs were calculated with the Clopper-Pearson method. Results included events with onset from the first dose of any study drug after surgery through 42 days after the last dose of any study drug. | Safety analysis population of all participants who started and received any study treatment during the adjuvant treatment period, grouped according to treatment received. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the first dose of any study drug after surgery through 42 days after the last dose of any study drug (during the adjuvant treatment period; up to approximately 39 weeks) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Adjuvant Treatment Period | LVEF significant decline was defined as the decline in LVEF of >/= 10%-points from baseline to an LVEF of < 50%. A Confirmed LVEF Significant Decline was defined as at least two consecutive readings of significant declines in LVEF. A Single LVEF Significant Decline was defined as only one reading of a significant decline (no consecutive readings) in LVEF. The category of 'At Least one LVEF Significant Decline Event' was defined as the total of confirmed and single LVEF significant declines. The 95% confidence intervals were calculated using the Clopper-Pearson method. Results included events with onset from the first dose of any study drug after surgery through 42 days after the last dose of any study drug. | Safety analysis population of all participants who started and received any study treatment during the adjuvant treatment period, grouped according to treatment received. | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of any study drug after surgery through 42 days after the last dose of any study drug (during the adjuvant treatment period; up to approximately 39 weeks) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Treatment-Free Follow-Up Period | Symptomatic left ventricular systolic dysfunction (otherwise referred to as heart failure) is a serious adverse event. The NYHA Functional Classification System for Heart Failure considers the patient's symptoms: Class III: Marked limitation of physical activity; Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort; Symptoms of heart failure at rest; If any physical activity is undertaken, discomfort increases. The 95% CIs were calculated with the Clopper-Pearson method. | Safety analysis population of all participants who received any study treatment during the study, grouped according to treatment received. | Posted | Number | 95% Confidence Interval | Percentage of participants | From 42 days after the last dose of study treatment until the end of treatment-free follow-up (up to 5 years) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Treatment-Free Follow-Up Period | LVEF significant decline was defined as the decline in LVEF of >/= 10%-points from baseline to an LVEF of < 50%. A Confirmed LVEF Significant Decline was defined as at least two consecutive readings of significant declines in LVEF. A Single LVEF Significant Decline was defined as only one reading of a significant decline (no consecutive readings) in LVEF. The category of 'At Least one LVEF Significant Decline Event' was defined as the total of confirmed and single LVEF significant declines. The 95% confidence intervals were calculated using the Clopper-Pearson method. | Safety analysis population of all participants who received any study treatment during the study, grouped according to treatment received. | Posted | Number | 95% Confidence Interval | Percentage of participants | From 42 days after the last dose of study treatment until the end of treatment-free follow-up (up to 5 years) |
| ||||||||||||||||||||||||||||||
| Secondary | Overview of the Number of Participants With at Least One Adverse Event During the Neoadjuvant Period | An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The terms "severe" and "serious" are not synonymous with respect to an AE. Severity refers to the intensity of an AE (rated according to NCI-CTCAE v4.0 criteria or, if not listed, the following scale: Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), whereas a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness needed to be independently assessed for each AE that was recorded. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as an AE with the term of ejection fraction decreased). In the results table, multiple occurrences of the same AE in one individual were counted only once. Any AE includes all serious and non-serious AEs. | Safety analysis population of all participants who received any study treatment during the neoadjuvant treatment period, grouped according to treatment received. | Posted | Count of Participants | Participants | From first dose of any study drug prior to surgery through the day before the first dose of study drug after surgery (up to 25 weeks) |
| |||||||||||||||||||||||||||||||
| Secondary | Overview of the Number of Participants With at Least One Adverse Event During the Adjuvant Period | An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The terms "severe" and "serious" are not synonymous with respect to an AE. Severity refers to the intensity of an AE (rated according to NCI-CTCAE v4.0 criteria or, if not listed, the following scale: Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), whereas a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness needed to be independently assessed for each AE that was recorded. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as an AE with the term of ejection fraction decreased). In the results table, multiple occurrences of the same AE in one individual were counted only once. Any AE includes all serious and non-serious AEs. | Safety analysis population of all participants who started and received any study treatment during the adjuvant treatment period, grouped according to treatment received. | Posted | Count of Participants | Participants | From the first dose of any study drug after surgery through 42 days after the last dose of any study drug (during the adjuvant treatment period; up to approximately 39 weeks) |
| |||||||||||||||||||||||||||||||
| Secondary | Overview of the Number of Participants With at Least One Adverse Event During the Treatment-Free Follow-Up Period | An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The terms "severe" and "serious" are not synonymous. Severity refers to the intensity of an AE (rated according to NCI-CTCAE v4.0 criteria or, if not listed, the following scale: Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), and a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness were independently assessed for each AE. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as ejection fraction decreased). During TFFU, only heart failure, pregnancies, and non-breast-related second primary malignancies, irrespective of causal relationship with study treatment, and drug-related SAEs were reported. Multiple occurrences of the same AE in 1 subject were counted only once. | Safety analysis population of all participants who received any study treatment during the study, grouped according to treatment received. | Posted | Count of Participants | Participants | From 42 days after the last dose of study treatment until the end of treatment-free follow-up (TFFU; up to 5 years) |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Positive for Anti-Therapeutic Antibodies (ATAs) to Pertuzumab at Baseline and Anytime Post-Baseline | ATAs to pertuzumab in serum samples were detected using a validated bridging enzyme-linked immunosorbent assay (ELISA) method. This analysis only included participants with an ATA assay result from a baseline sample and/or at least one post-baseline sample. | This analysis only included participants with an ATA assay result from a baseline sample and/or at least one post-baseline sample. | Posted | Number | Percentage of participants | Screening (baseline) then prior to pertuzumab infusion (Hour 0) in Cycles 5, 14, 18 thereafter anytime between Cycle 8 Day 21 and surgery, up to treatment completion visit (cycle length=2-3 weeks; up to approximately 1 year, 3 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Total Pathologic Complete Response (tpCR), Evaluated After Surgery | Total pathologic complete response (tpCR) was the pCR based on tumor and nodal staging (i.e., histological confirmation of pCR in breast and nodes at surgery) and was defined as the absence of any residual invasive cancer in the breast and the absence of any metastatic cells in the regional lymph nodes (i.e., ypT0/is ypN0 tpCR). Participants who did not undergo surgery or did not have a valid pCR assessment were considered non-responders in the analysis. The 95% CIs were calculated using the Clopper-Pearson method. | ITT population: included all participants who were enrolled regardless of whether they received any study treatment, grouped according to the arm to which a participant was enrolled. | Posted | Number | 95% Confidence Interval | Percentage of participants | After completion of neoadjuvant treatment and surgery (up to 25 weeks) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Response as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 During the Neoadjuvant Treatment Period | The clinical response rate was defined as the percentage of participants in the ITT population who achieved a complete response (CR) or partial response (PR) prior to surgery, according to RECIST v1.1. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter compared to Baseline. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Progressive Disease (PD): at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. Participants were classified as missing or unevaluable if no assessments were measured prior to surgery on the ipsilateral breast. The 95% CIs were calculated using the Clopper-Pearson method; they were only calculated for responses (not for missing or unevaluable data). | ITT population: included all participants who were enrolled regardless of whether they received any study treatment, grouped according to the arm to which a participant was enrolled. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Baseline until disease progression or death due to any cause up to 24 weeks (during the neoadjuvant treatment period; assessed on Day 1 of Cycles 1-8 [cycle length=2-3 weeks]) |
| ||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Event-Free Survival (EFS) at 1 to 5 Years, Determined by the Investigator According to RECIST v1.1 | The Kaplan-Meier method was used to estimate the percentage of participants who were event-free at landmark timepoints. Event-free survival (EFS) was defined as the time from enrollment to the first occurrence of progressive disease (PD), relapse, or death from any cause, with tumor evaluations performed by the investigator according to RECIST v1.1. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) were not counted as progressive disease or relapse. Participants who withdrew from the study without documented progression or relapse and for whom there existed evidence that evaluations had been made, were censored at the date of the last assessment at which the participant was known to be free from progressive disease or relapse. Participants with no tumor evaluations after baseline were censored at the date of enrollment plus 1 day. | ITT population: included all participants who were enrolled regardless of whether they received any study treatment, grouped according to the arm to which a participant was enrolled. The number analyzed per timepoint represents the number of participants remaining at risk at that timepoint. | Posted | Number | 95% Confidence Interval | Estimate of percentage of participants | At 1, 2, 3, 4, and 5 years |
| ||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Invasive Disease-Free Survival (iDFS) at 1 to 4 Years, Determined by the Investigator According to RECIST v1.1 | The Kaplan-Meier method was used to estimate the percentage of participants who were event-free at landmark timepoints. Invasive disease-free survival (iDFS) was defined as the time from the first date of no disease (the date of surgery) to the first documentation of progressive invasive disease, relapse, or death, with tumor evaluations performed by the investigator according to RECIST v1.1. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) were not counted as progressive disease or relapse. Participants who withdrew from the study without documented progression or relapse and for whom there existed evidence that evaluations had been made, were censored at the date of the last assessment at which the participant was known to be alive and disease-free. Participants with no postbaseline information and participants who did not undergo surgery were excluded from the analysis. | ITT population: included all participants who were enrolled regardless of whether they received any study treatment, grouped according to the arm to which a participant was enrolled. Participants with no post-baseline information and those who did not undergo surgery were excluded from the analysis. The number analyzed per timepoint represents the number of participants remaining at risk at that timepoint. | Posted | Number | 95% Confidence Interval | Estimate of percentage of participants | At 1, 2, 3, and 4 years |
| ||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Overall Survival (OS) at 1 to 5 Years | The Kaplan-Meier method was used to estimate the percentage of participants who were event-free at landmark timepoints. Overall survival (OS) was defined as the time from enrollment to death from any cause. Participants who were alive or lost to follow-up were censored at their last known date in the study. Participants with no post-baseline assessments were censored at the date of enrollment plus 1 day. | ITT population: included all participants who were enrolled regardless of whether they received any study treatment, grouped according to the arm to which a participant was enrolled. The number analyzed per timepoint represents the number of participants remaining at risk at that timepoint. | Posted | Number | 95% Confidence Interval | Estimate of percentage of participants | At 1, 2, 3, 4, and 5 years |
|
From first dose of any study drug until the end of treatment-free follow-up (up to 6 years, 1 month)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams [mg] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram [mg/kg] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. | 7 | 199 | 56 | 199 | 197 | 199 |
| EG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. | 13 | 198 | 66 | 198 | 198 | 198 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AGRANULOCYTOSIS | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| BONE MARROW FAILURE | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ATRIAL THROMBOSIS | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HAEMORRHOIDAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| NEUTROPENIC COLITIS | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ODYNOPHAGIA | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PROCTALGIA | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| BREAST CELLULITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| MASTITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| PERITONITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| POST PROCEDURAL INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| PSEUDOMONAL BACTERAEMIA | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| VASCULAR DEVICE INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| SEROMA | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| WOUND DECOMPOSITION | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| EJECTION FRACTION DECREASED | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| TRANSAMINASES INCREASED | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| NON-HODGKIN'S LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| PLASMA CELL MYELOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| RENAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| CEREBELLAR SYNDROME | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| BREAST HAEMATOMA | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PAINFUL RESPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ERYTHEMA MULTIFORME | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| SKIN NECROSIS | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ABORTION INDUCED | Surgical and medical procedures | MedDRA v23.0 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| LACRIMATION INCREASED | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MOUTH ULCERATION | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ODYNOPHAGIA | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| RADIATION SKIN INJURY | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| EJECTION FRACTION DECREASED | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| AMENORRHOEA | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
| |
| BREAST PAIN | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
| |
| VULVOVAGINAL DRYNESS | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| UPPER-AIRWAY COUGH SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| NAIL DISCOLOURATION | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| NAIL TOXICITY | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ONYCHOCLASIS | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ONYCHOLYSIS | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ONYCHOMADESIS | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| SKIN HYPERPIGMENTATION | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
| |
| LYMPHOEDEMA | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D003520 | Cyclophosphamide |
| D000077143 | Docetaxel |
| D004317 | Doxorubicin |
| D015251 | Epirubicin |
| D017239 | Paclitaxel |
| C485206 | pertuzumab |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
|
|
| OG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
|
|
| OG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
|
|
| OG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
|
|
| OG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
|
|
| OG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
|
|
| OG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
|
|
| OG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
|
|
| OG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
|
|
| OG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
|
|
| OG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
|
|
| OG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
|
|
Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams [mg] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram [mg/kg] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
| OG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
|
|
| OG001 | Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m^2 intravenously (IV) q3w, epirubicin 100mg/m^2 IV q3w, and cyclophosphamide 600mg/m^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years. |
|
|