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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004897-32 | EudraCT Number |
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This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Active Comparator | Participants will receive 8 cycles of investigator's choice of neoadjuvant chemotherapy. This will include either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor [G-CSF] support as needed according to local guidelines) followed by paclitaxel Q1W for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab will be given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants will undergo surgery. Thereafter, participants will receive an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles. |
|
| Arm B: FDC of Pertuzumab and Trastuzumab SC + Chemotherapy | Experimental | Participants will receive 8 cycles of investigator's choice of neoadjuvant chemotherapy. This will include either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab will be given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants will undergo surgery. Thereafter, participants will receive an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide 600 mg/m2 will be administered IV on Day 1 of each cycle of treatment (as part of ddAC Q2W or AC Q3W) for Cycles 1-4. |
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| Measure | Description | Time Frame |
|---|---|---|
| Trough Serum Concentration (Ctrough) of Pertuzumab During Cycle 7 (Pre-Dose Cycle 8) | The observed pertuzumab trough serum concentration (Ctrough) at Cycle 7 was assessed following 3 cycles of pertuzumab IV and trastuzumab IV or the fixed-dose combination (FDC) of pertuzumab and trastuzumab SC. The Per Protocol Pharmacokinetics (PK) analysis population includes all enrolled participants who adhered to the protocol. Exclusions from the Per Protocol PK analysis population were made for the following reasons: participants were missing the Ctrough pre-dose Cycle 8 PK sample, participants with a Ctrough sample collected with at least 2 days deviation from the planned date on Day 21 (i.e., before Day 19 or after Day 23), participants given a dose amount that deviated from the planned dose by >20% within 3 cycles (from Cycle 5), participants with a dose delay of more than 7 days, a subcutaneous injection site other than thigh was used, if the Cycle 8 pre-dose and post-dose samples were switched, and an assay error impacting Ctrough measurement. | Pre-dose on Cycle 8, Day 1 (up to 21 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Ctrough of Trastuzumab During Cycle 7 (Pre-Dose Cycle 8) | The observed trastuzumab trough serum concentration (Ctrough) at Cycle 7 was assessed following 3 cycles of pertuzumab IV and trastuzumab IV or the fixed-dose combination (FDC) of pertuzumab and trastuzumab SC. The Per Protocol Pharmacokinetics (PK) analysis population includes all enrolled participants who adhered to the protocol. Exclusions from the Per Protocol PK analysis population were made for the following reasons: participants were missing the Ctrough pre-dose Cycle 8 PK sample, participants with a Ctrough sample collected with at least 2 days deviation from the planned date on Day 21 (i.e., before Day 19 or after Day 23), participants given a dose amount that deviated from the planned dose by >20% within 3 cycles (from Cycle 5), participants with a dose delay of more than 7 days, a subcutaneous injection site other than thigh was used, if the Cycle 8 pre-dose and post-dose samples were switched, and an assay error impacting Ctrough measurement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maryland Oncology Hematology | Rockville | Maryland | 20850 | United States | ||
| San Juan Oncology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33357420 | Derived | Tan AR, Im SA, Mattar A, Colomer R, Stroyakovskii D, Nowecki Z, De Laurentiis M, Pierga JY, Jung KH, Schem C, Hogea A, Badovinac Crnjevic T, Heeson S, Shivhare M, Kirschbrown WP, Restuccia E, Jackisch C; FeDeriCa study group. Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study. Lancet Oncol. 2021 Jan;22(1):85-97. doi: 10.1016/S1470-2045(20)30536-2. Epub 2020 Dec 21. |
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Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).
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A total of 607 patients were screened, 500 of whom were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor [G-CSF] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 (neo)adjuvant anti-HER2 treatment cycles. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Neoadjuvant Treatment Phase (24 Weeks) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2018 | Jun 3, 2020 |
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| Doxorubicin | Drug | Doxorubicin 60 mg/m2 will be administered IV on Day 1 of each cycle of treatment (as part of either ddAC Q2W or AC Q3W) for Cycles 1-4. |
|
| Docetaxel | Drug | As part of one of the two investigator's choices of chemotherapy (AC followed by docetaxel), docetaxel 75 mg/m2 will be administered IV on Day 1 of Cycle 5 and then 100 mg/m2 IV at the discretion of the investigator for Cycles 6-8 (Q3W), if no dose-limiting toxicity occurs. |
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| Paclitaxel | Drug | As part of one of the two investigator's choices of chemotherapy (ddAC followed by paclitaxel), paclitaxel 80 mg/m2 will be administered IV QW for 12 weeks. |
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| Pertuzumab IV | Drug | Pertuzumab will be administered as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose Q3W. |
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| FDC of Pertuzumab and Trastuzumab SC | Drug | The FDC of pertuzumab and trastuzumab will be administered SC at a fixed non-weight-based dose. A loading dose of 1200 mg SC pertuzumab and 600 mg SC trastuzumab is then followed by a maintenance dose of 600 mg SC pertuzumab and 600 mg SC trastuzumab Q3W. |
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| Trastuzumab IV | Drug | Trastuzumab will be administered as an 8-mg/kg IV loading dose and then 6 mg/kg IV maintenance dose Q3W. |
|
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| Trastuzumab SC | Drug | After surgery (from Cycle 9 onwards), participants in Arm A will be allowed to switch from trastuzumab IV to trastuzumab SC, at the discretion of the investigator, in the countries where trastuzumab SC is routinely used. For participants who switch, a fixed dose of 600 mg trastuzumab SC (irrespective of the patient's weight) will be administered in the adjuvant phase. |
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| Surgery | Procedure | Participants in both cohorts are scheduled to undergo surgery after 8 cycles of neoadjuvant therapy. Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice. |
|
| Post-operative Radiotherapy | Radiation | If indicated, radiotherapy is given after chemotherapy and surgery, during adjuvant HER2-targeted therapy and hormone therapy (for hormone-receptor positive disease). |
|
| Hormone Therapy | Drug | For hormone receptor positive breast cancer, tamoxifen or aromatase inhibitors will be allowed as adjuvant hormone therapy for postmenopausal participants and with ovarian suppression or ablation for premenopausal participants in countries where it has been registered for this indication. Its use must be consistent with the registered label. Hormone therapy is given after chemotherapy and surgery during adjuvant HER2-targeted therapy. |
|
| Pre-dose on Cycle 8, Day 1 (up to 21 weeks) |
| Percentage of Participants With Total Pathological Complete Response (tpCR), According to Local Pathologist Assessment | Total pCR (tpCR) was defined as eradication of invasive disease in the breast and axilla; that is, ypT0/is ypN0, according to the local pathologists' assessment. Pathologic response to therapy was determined at the time of surgery. The tpCR rate is the percentage of participants in the ITT population who achieved a tpCR. Participants with missing data for tpCR (i.e., do not undergo surgery or have an invalid pCR assessment) were included in the analysis and classified as non-responders. Rates of tpCR were calculated in each treatment arm and were assessed using the difference between the Arm B: Pertuzumab and Trastuzumab FDC SC and the Arm A: Pertuzumab IV and Trastuzumab IV tpCR rates and corresponding 95% Clopper-Pearson confidence intervals (CIs). The difference between the tpCR rates along with corresponding 95% Hauck-Anderson CIs were calculated. The lower bound of the CI will reliably reflect the largest tpCR difference that can be considered unlikely. | Following completion of surgery (up to 33 weeks) |
| Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to Invasive Disease-Free Survival (iDFS; Excluding Second Primary Non-Breast Cancer [SPNBC]) Criteria | iDFS (excluding SPNBC) is defined as the time from the first date of no disease (i.e., the date of primary surgery) to the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence; ipsilateral local-regional invasive breast cancer reccurrence; distant recurrence; contralateral invasive breast cancer; or death attributable to any cause. Ipsilateral or contralateral in situ disease and SPNBC (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or relapse. | At 1, 2, 3, and 4 years |
| Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to iDFS (Including SPNBC) Criteria | Invasive disease-free survival (iDFS) including second primary non-breast cancer (SPNBC) is defined as the time from the first date of no disease (i.e., the date of primary surgery) to the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence; ipsilateral local-regional invasive breast cancer reccurrence; distant recurrence; contralateral invasive breast cancer; or death attributable to any cause. It also includes SPNBC as an event (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). | At 1, 2, 3, and 4 years |
| Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to Event-Free Survival (EFS; Excluding SPNBC) Criteria | Event-free survival (EFS) excluding second primary non-breast cancer (SPNBC) is defined as the time from enrollment to the first occurrence of one of the following events: breast cancer progression; breast cancer recurrence; or death from any cause. Ipsilateral or contralateral in situ disease and SPNBC (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or relapse. | At 1, 2, 3, and 4 years |
| Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to EFS (Including SPNBC) Criteria | Event-free survival (EFS) including second primary non-breast cancer (SPNBC) is defined as the time from enrollment to the first occurrence of one of the following events: breast cancer progression; breast cancer recurrence; or death from any cause. It also includes SPNBC as an event (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). | At 1, 2, 3, and 4 years |
| Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to Distant Recurrence-Free Interval (DRFI) Criteria | The distant recurrence-free interval (DRFI) is defined as the time between randomization and the date of distant breast cancer recurrence. | At 1, 2, 3, and 4 years |
| Kaplan-Meier Estimate of the Percentage of Participants in Overall Survival | Overall survival is defined as the time from randomization to death from any cause. | At 1, 2, 3, and 4 years |
| Summary of the Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0), Over the Course of the Entire Study | The adverse event (AE) severity grading scale for the NCI CTCAE v4.0 was used for assessing AE severity. Any AEs that were not specifically listed in the NCI CTCAE, v4.0 were graded per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. | From first dose of study treatment until 28 days after last dose of study treatment (up to 1 year, 6 months) |
| Number of Participants With a Primary Cardiac Event During the Neoadjuvant Phase | A primary cardiac event is defined as the occurrence of either of the following events: - Incidence of a symptomatic ejection fraction decrease (heart failure) of New York Heart Association (NYHA) Class III or IV and a drop in left ventricular ejection fraction (LVEF) of at least 10-percentage points from baseline and to below 50%; or - Cardiac death, defined as: Definite cardiac death (due to heart failure, myocardial infarction, or documented primary arrhythmia); or, Probable cardiac death (sudden unexpected death within 24 hours of a definite or probable cardiac event [e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia] without documented etiology). | From first dose of study treatment until the completion of neoadjuvant therapy (24 weeks) |
| Number of Participants With a Secondary Cardiac Event During the Neoadjuvant Phase | A secondary cardiac event is defined as asymptomatic or mildly symptomatic Left Ventricular Systolic Dysfunction (LVSD) of NYHA Class II, defined as a left ventricular ejection fraction (LVEF) decrease of at least 10-percentage points below the baseline measurement to an absolute LVEF value of <50% confirmed by a second assessment within approximately 3 weeks. | From first dose of study treatment until the completion of neoadjuvant therapy (24 weeks) |
| Number of Participants With a Primary Cardiac Event During the Adjuvant Phase | A primary cardiac event is defined as the occurrence of either of the following events: - Incidence of a symptomatic ejection fraction decrease (heart failure) of New York Heart Association (NYHA) Class III or IV and a drop in left ventricular ejection fraction (LVEF) of at least 10-percentage points from baseline and to below 50%; or - Cardiac death, defined as: Definite cardiac death (due to heart failure, myocardial infarction, or documented primary arrhythmia); or, Probable cardiac death (sudden unexpected death within 24 hours of a definite or probable cardiac event [e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia] without documented etiology). | From surgery until 28 days after the last dose of adjuvant treatment (42 weeks) |
| Number of Participants With a Secondary Cardiac Event During the Adjuvant Phase | A secondary cardiac event is defined as asymptomatic or mildly symptomatic Left Ventricular Systolic Dysfunction (LVSD) of NYHA Class II, defined as a left ventricular ejection fraction (LVEF) decrease of at least 10-percentage points below the baseline measurement to an absolute LVEF value of <50% confirmed by a second assessment within approximately 3 weeks. | From surgery until 28 days after the last dose of adjuvant treatment (42 weeks) |
| Number of Participants With Laboratory Test Abnormalities at the Highest NCI CTCAE v4 Grade Post-Baseline Over the Course of the Entire Study | Clinical laboratory tests were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest (worst) severity grade (according to NCI-CTCAE v4.0) post-baseline. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a medical intervention or a change in concomitant therapy. For a participant with multiple post-baseline abnormalities, only the highest (worst) grade for a given laboratory test is reported. 'Any Grade' indicates the total number of participants with a post-baseline abnormality of any grade for the specified test. | From first dose of study treatment until 28 days after last dose of study treatment (up to 1 year, 6 months) |
| Farmington |
| New Mexico |
| 87401 |
| United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Northwest Medical Specialties | Lakewood | Washington | 98499 | United States |
| Fundación CENIT para la Investigación en Neurociencias | Buenos Aires | C1125ABD | Argentina |
| Centro Oncologico Riojano Integral (CORI) | La Rioja | F5300COE | Argentina |
| COIBA | Provincia de Buenos Aires | B1884BBF | Argentina |
| Institut Jules Bordet | Anderlecht | 1070 | Belgium |
| GHdC Site Notre Dame | Charleroi | 6000 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| Jessa Zkh (Campus Virga Jesse) | Hasselt | 3500 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Clinique Ste-Elisabeth | Namur | 5000 | Belgium |
| Hospital Araujo Jorge; Departamento de Ginecologia E Mama | Goiânia | Goiás | 74605-070 | Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 90040-373 | Brazil |
| Hospital Perola Byington | São Paulo | São Paulo | 01317-000 | Brazil |
| Royal Victoria Hospital | Barrie | Ontario | L4M 6M2 | Canada |
| Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center | Oshawa | Ontario | L1G 2B9 | Canada |
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | K2H 6C2 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Masarykuv onkologicky ustav | Brno | 656 53 | Czechia |
| Multiscan s.r.o. | Pardubice | 532 03 | Czechia |
| ICO Paul Papin; Oncologie Medicale. | Angers | 49055 | France |
| Institut Sainte Catherine | Avignon | 84082 | France |
| CHRU Besançon | Besançon | 25030 | France |
| Institut Bergonie; Oncologie | Bordeaux | 33076 | France |
| Centre Léon Bérard | Lyon | 69373 | France |
| Institut Curie; Oncologie Medicale | Paris | 75231 | France |
| APHP - Hospital Saint Louis | Paris | 75475 | France |
| ICO - Site René Gauducheau | Saint-Herblain | 44805 | France |
| Klinikum Augsburg; Frauenklinik | Augsburg | 86156 | Germany |
| Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie | Bad Nauheim | 61231 | Germany |
| Onkologische Schwerpunktpraxis Kurfürstendamm | Berlin | 10707 | Germany |
| St. Johannes-Hospital | Dortmund | 44137 | Germany |
| Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum | Essen | 45136 | Germany |
| Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem | Hamburg | 20357 | Germany |
| Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe | Offenbach | 63069 | Germany |
| Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher | Stralsund | 18439 | Germany |
| Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica | Naples | Campania | 80131 | Italy |
| Università degli Studi Federico II; Clinica di Oncologia Medica | Naples | Campania | 80131 | Italy |
| Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica | Aviano | Friuli Venezia Giulia | 33081 | Italy |
| Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico | Genoa | Liguria | 16132 | Italy |
| ASST DI LECCO; Oncologia Medica | Lecco | Lombardy | 23900 | Italy |
| IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II | Padova | Veneto | 35128 | Italy |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| Gifu University Hospital | Gifu | 501-1194 | Japan |
| Hiroshima City Hiroshima Citizens Hospital | Hiroshima | 730-8518 | Japan |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| National Hospital Organization Hokkaido Cancer Center | Hokkaido | 003-0804 | Japan |
| Hyogo Medical University Hospital | Hyōgo | 663-8501 | Japan |
| Sagara Hospital | Kagoshima | 892-0833 | Japan |
| Kanagawa Cancer Center | Kanagawa | 241-8515 | Japan |
| Tokai University Hospital | Kanagawa | 259-1193 | Japan |
| Fukushima Medical University Hospital | Miyagi | 960-1295 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Osaka International Cancer Institute | Osaka | 541-8567 | Japan |
| Saitama Medical University International Medical Center | Saitama | 350-1298 | Japan |
| St. Luke's International Hospital | Tokyo | 104-8560 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135-8550 | Japan |
| Iem-Fucam | D.F. | Mexico CITY (federal District) | 04980 | Mexico |
| Centro Médico Zambrano Hellion | Monterrey | Nuevo León | 66278 | Mexico |
| Oncologico Potosino | San Luis Potosí City | San Luis Potosí | 78209 | Mexico |
| Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie | Bialystok | 15-027 | Poland |
| Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi | Gliwice | 44-101 | Poland |
| Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna | Krakow | 31-501 | Poland |
| Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych | Szczecin | 71-730 | Poland |
| Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr | Warsaw | 02-781 | Poland |
| Dolnoslaskie Centrum Onkologii | Wroclaw | 53-439 | Poland |
| Arkhangelsk Regional Clinical Oncology Dispensary | Arkhangelsk | Arhangelsk | 163045 | Russia |
| Moscow City Oncology Hospital #62 | Moscovskaya Oblast | Moscow Oblast | 143423 | Russia |
| S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| Clinical Oncology Dispensary of Ministry of Health of Tatarstan | Kazan' | Tatarstan Republic | 420029 | Russia |
| Ivanovo Regional Oncology Dispensary | Ivanovo | 153040 | Russia |
| Omsk Region Clinical Oncology Dispensary; 1St Sergical Department | Omsk | 644013 | Russia |
| Seoul National University Bundang Hospital | Seongnam-si | 463-707 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Ulsan University Hosiptal | Ulsan | 44033 | South Korea |
| Hospital Universitario Reina Sofia; Servicio de Oncologia | Córdoba | Cordoba | 14004 | Spain |
| Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia | Santiago de Compostela | LA Coruña | 15706 | Spain |
| Hospital de Cruces; Servicio de Oncología Médica | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital del Mar; Servicio de Oncologia | Barcelona | 08003 | Spain |
| Institut Catala d Oncologia Hospital Duran i Reynals | Barcelona | 08908 | Spain |
| Hospital Universitario La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| Hospital Universitario Virgen del Rocio; Servicio de Oncologia | Seville | 41013 | Spain |
| Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia | Valencia | 46010 | Spain |
| China Medical University Hospital; Surgery | Taichung | 404 | Taiwan |
| VETERANS GENERAL HOSPITAL; Department of General Surgery | Taipei | 00112 | Taiwan |
| Chang Gung Medical Foundation - Linkou; Dept of Surgery | Taoyuan | 333 | Taiwan |
| Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology | Bangkok | 10700 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial | Chiang Mai | 50200 | Thailand |
| Songklanagarind Hospital; Department of Surgery | Songkhla | 90110 | Thailand |
| Municipal Noncommercial Institution Regional Center of Oncology | Kharkiv | Kharkiv Governorate | 61070 | Ukraine |
| Chemotherapy SI Dnipropetrovsk MA of MOHU | Dnipropetrovsk | 49102 | Ukraine |
| National Cancer Institute MOH of Ukraine | Kiev | 36022 | Ukraine |
| Lviv State Oncology Regional Treatment and Diagnostic Centre | Lviv | 79031 | Ukraine |
| RCI Sumy Regional Clinical Oncological Dispensary | Sumy | 40005 | Ukraine |
| Brighton and Sussex Univ Hosp | Brighton | BN2 5BD | United Kingdom |
| Velindre Cancer Centre | Cardiff | CF14 2TL | United Kingdom |
| St Georges University Hospitals NHS Foundation Trust | London | SW17 0RE | United Kingdom |
| Christie Hospital NHS Trust | Manchester | M20 4BX | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Peterborough City Hospital | Peterborough | PE3 9GZ | United Kingdom |
| FG001 | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 (neo)adjuvant anti-HER2 treatment cycles. |
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| Received at Least One Dose of Study Drug | Safety Population |
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| COMPLETED |
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| NOT COMPLETED |
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| Surgery & Adjuvant Treatment (42 Weeks) |
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| Treatment-Free Follow-Up (up to 3 Years) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor [G-CSF] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles. |
| BG001 | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles. |
| 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 |
| ||||||||||||||||
| Randomization Stratification Factors: Hormone Receptor Status | Hormone receptor status was based on central assessment of participant samples for estrogen receptor (ER) and progesterone receptor (PgR) negativity or positivity. | Count of Participants | Participants |
| |||||||||||||||
| Randomization Stratification Factors: Clinical Stage at Presentation | Count of Participants | Participants |
| ||||||||||||||||
| Randomization Stratification Factors: Neoadjuvant Chemotherapy Regimen | AC = doxorubicin plus cyclophosphamide; ddAC = dose-dense doxorubicin plus cyclophosphamide | 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 | Trough Serum Concentration (Ctrough) of Pertuzumab During Cycle 7 (Pre-Dose Cycle 8) | The observed pertuzumab trough serum concentration (Ctrough) at Cycle 7 was assessed following 3 cycles of pertuzumab IV and trastuzumab IV or the fixed-dose combination (FDC) of pertuzumab and trastuzumab SC. The Per Protocol Pharmacokinetics (PK) analysis population includes all enrolled participants who adhered to the protocol. Exclusions from the Per Protocol PK analysis population were made for the following reasons: participants were missing the Ctrough pre-dose Cycle 8 PK sample, participants with a Ctrough sample collected with at least 2 days deviation from the planned date on Day 21 (i.e., before Day 19 or after Day 23), participants given a dose amount that deviated from the planned dose by >20% within 3 cycles (from Cycle 5), participants with a dose delay of more than 7 days, a subcutaneous injection site other than thigh was used, if the Cycle 8 pre-dose and post-dose samples were switched, and an assay error impacting Ctrough measurement. | Per Protocol PK Population: includes only participants who adhered to the pre-specified criteria for the schedule of pharmacokinetic assessments. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per millilitre (μg/mL) | Pre-dose on Cycle 8, Day 1 (up to 21 weeks) |
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| Secondary | Ctrough of Trastuzumab During Cycle 7 (Pre-Dose Cycle 8) | The observed trastuzumab trough serum concentration (Ctrough) at Cycle 7 was assessed following 3 cycles of pertuzumab IV and trastuzumab IV or the fixed-dose combination (FDC) of pertuzumab and trastuzumab SC. The Per Protocol Pharmacokinetics (PK) analysis population includes all enrolled participants who adhered to the protocol. Exclusions from the Per Protocol PK analysis population were made for the following reasons: participants were missing the Ctrough pre-dose Cycle 8 PK sample, participants with a Ctrough sample collected with at least 2 days deviation from the planned date on Day 21 (i.e., before Day 19 or after Day 23), participants given a dose amount that deviated from the planned dose by >20% within 3 cycles (from Cycle 5), participants with a dose delay of more than 7 days, a subcutaneous injection site other than thigh was used, if the Cycle 8 pre-dose and post-dose samples were switched, and an assay error impacting Ctrough measurement. | Per Protocol PK Population: includes only participants who adhered to the pre-specified criteria for the schedule of pharmacokinetic assessments. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milllilitre (μg/mL) | Pre-dose on Cycle 8, Day 1 (up to 21 weeks) |
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| Secondary | Percentage of Participants With Total Pathological Complete Response (tpCR), According to Local Pathologist Assessment | Total pCR (tpCR) was defined as eradication of invasive disease in the breast and axilla; that is, ypT0/is ypN0, according to the local pathologists' assessment. Pathologic response to therapy was determined at the time of surgery. The tpCR rate is the percentage of participants in the ITT population who achieved a tpCR. Participants with missing data for tpCR (i.e., do not undergo surgery or have an invalid pCR assessment) were included in the analysis and classified as non-responders. Rates of tpCR were calculated in each treatment arm and were assessed using the difference between the Arm B: Pertuzumab and Trastuzumab FDC SC and the Arm A: Pertuzumab IV and Trastuzumab IV tpCR rates and corresponding 95% Clopper-Pearson confidence intervals (CIs). The difference between the tpCR rates along with corresponding 95% Hauck-Anderson CIs were calculated. The lower bound of the CI will reliably reflect the largest tpCR difference that can be considered unlikely. | ITT Population: includes all enrolled participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Following completion of surgery (up to 33 weeks) |
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| Secondary | Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to Invasive Disease-Free Survival (iDFS; Excluding Second Primary Non-Breast Cancer [SPNBC]) Criteria | iDFS (excluding SPNBC) is defined as the time from the first date of no disease (i.e., the date of primary surgery) to the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence; ipsilateral local-regional invasive breast cancer reccurrence; distant recurrence; contralateral invasive breast cancer; or death attributable to any cause. Ipsilateral or contralateral in situ disease and SPNBC (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or relapse. | The analysis population included all participants who had undergone surgery. The number analyzed at each landmark timepoint represents the number of participants who were remaining at risk for an event. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1, 2, 3, and 4 years |
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| Secondary | Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to iDFS (Including SPNBC) Criteria | Invasive disease-free survival (iDFS) including second primary non-breast cancer (SPNBC) is defined as the time from the first date of no disease (i.e., the date of primary surgery) to the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence; ipsilateral local-regional invasive breast cancer reccurrence; distant recurrence; contralateral invasive breast cancer; or death attributable to any cause. It also includes SPNBC as an event (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). | The analysis population included all participants who had undergone surgery. The number analyzed at each landmark timepoint represents the number of participants who were remaining at risk for an event. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1, 2, 3, and 4 years |
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| Secondary | Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to Event-Free Survival (EFS; Excluding SPNBC) Criteria | Event-free survival (EFS) excluding second primary non-breast cancer (SPNBC) is defined as the time from enrollment to the first occurrence of one of the following events: breast cancer progression; breast cancer recurrence; or death from any cause. Ipsilateral or contralateral in situ disease and SPNBC (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or relapse. | ITT Population. The number analyzed at each landmark timepoint represents the number of participants who were remaining at risk for an event. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1, 2, 3, and 4 years |
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| Secondary | Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to EFS (Including SPNBC) Criteria | Event-free survival (EFS) including second primary non-breast cancer (SPNBC) is defined as the time from enrollment to the first occurrence of one of the following events: breast cancer progression; breast cancer recurrence; or death from any cause. It also includes SPNBC as an event (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). | ITT Population. The number analyzed at each landmark timepoint represents the number of participants who were remaining at risk for an event. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1, 2, 3, and 4 years |
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| Secondary | Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to Distant Recurrence-Free Interval (DRFI) Criteria | The distant recurrence-free interval (DRFI) is defined as the time between randomization and the date of distant breast cancer recurrence. | ITT Population. The number analyzed at each landmark timepoint represents the number of participants who were remaining at risk for an event. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1, 2, 3, and 4 years |
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| Secondary | Kaplan-Meier Estimate of the Percentage of Participants in Overall Survival | Overall survival is defined as the time from randomization to death from any cause. | ITT Population. The number analyzed at each landmark timepoint represents the number of participants who were remaining at risk for an event. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1, 2, 3, and 4 years |
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| Secondary | Summary of the Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0), Over the Course of the Entire Study | The adverse event (AE) severity grading scale for the NCI CTCAE v4.0 was used for assessing AE severity. Any AEs that were not specifically listed in the NCI CTCAE, v4.0 were graded per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. | Safety Population: includes all participants who received at least one dose of study medication. | Posted | Count of Participants | Participants | From first dose of study treatment until 28 days after last dose of study treatment (up to 1 year, 6 months) |
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| Secondary | Number of Participants With a Primary Cardiac Event During the Neoadjuvant Phase | A primary cardiac event is defined as the occurrence of either of the following events: - Incidence of a symptomatic ejection fraction decrease (heart failure) of New York Heart Association (NYHA) Class III or IV and a drop in left ventricular ejection fraction (LVEF) of at least 10-percentage points from baseline and to below 50%; or - Cardiac death, defined as: Definite cardiac death (due to heart failure, myocardial infarction, or documented primary arrhythmia); or, Probable cardiac death (sudden unexpected death within 24 hours of a definite or probable cardiac event [e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia] without documented etiology). | Safety Population: includes all participants who received at least one dose of study medication. | Posted | Count of Participants | Participants | From first dose of study treatment until the completion of neoadjuvant therapy (24 weeks) |
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| Secondary | Number of Participants With a Secondary Cardiac Event During the Neoadjuvant Phase | A secondary cardiac event is defined as asymptomatic or mildly symptomatic Left Ventricular Systolic Dysfunction (LVSD) of NYHA Class II, defined as a left ventricular ejection fraction (LVEF) decrease of at least 10-percentage points below the baseline measurement to an absolute LVEF value of <50% confirmed by a second assessment within approximately 3 weeks. | Safety Population: includes all participants who received at least one dose of study medication. | Posted | Count of Participants | Participants | From first dose of study treatment until the completion of neoadjuvant therapy (24 weeks) |
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| Secondary | Number of Participants With a Primary Cardiac Event During the Adjuvant Phase | A primary cardiac event is defined as the occurrence of either of the following events: - Incidence of a symptomatic ejection fraction decrease (heart failure) of New York Heart Association (NYHA) Class III or IV and a drop in left ventricular ejection fraction (LVEF) of at least 10-percentage points from baseline and to below 50%; or - Cardiac death, defined as: Definite cardiac death (due to heart failure, myocardial infarction, or documented primary arrhythmia); or, Probable cardiac death (sudden unexpected death within 24 hours of a definite or probable cardiac event [e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia] without documented etiology). | Safety Population: includes all participants who received at least one dose of study medication. | Posted | Count of Participants | Participants | From surgery until 28 days after the last dose of adjuvant treatment (42 weeks) |
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| Secondary | Number of Participants With a Secondary Cardiac Event During the Adjuvant Phase | A secondary cardiac event is defined as asymptomatic or mildly symptomatic Left Ventricular Systolic Dysfunction (LVSD) of NYHA Class II, defined as a left ventricular ejection fraction (LVEF) decrease of at least 10-percentage points below the baseline measurement to an absolute LVEF value of <50% confirmed by a second assessment within approximately 3 weeks. | Safety Population: includes all participants who received at least one dose of study medication. | Posted | Count of Participants | Participants | From surgery until 28 days after the last dose of adjuvant treatment (42 weeks) |
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| Secondary | Number of Participants With Laboratory Test Abnormalities at the Highest NCI CTCAE v4 Grade Post-Baseline Over the Course of the Entire Study | Clinical laboratory tests were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest (worst) severity grade (according to NCI-CTCAE v4.0) post-baseline. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a medical intervention or a change in concomitant therapy. For a participant with multiple post-baseline abnormalities, only the highest (worst) grade for a given laboratory test is reported. 'Any Grade' indicates the total number of participants with a post-baseline abnormality of any grade for the specified test. | Safety Population: includes all participants who received at least one dose of study medication. The number analyzed varies because it indicates all participants with a post-baseline laboratory value for a given test within the timeframe. | Posted | Count of Participants | Participants | From first dose of study treatment until 28 days after last dose of study treatment (up to 1 year, 6 months) |
|
Adverse events (AEs): From first dose of study treatment until 28 days after last dose of study treatment (up to 1 year, 6 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 4 years, 11 months)
After initiation of study drug, all AEs were reported until 28 days after the last dose of study drug. After this period, only drug-related serious AEs, heart failure, pregnancies, and malignancies were reported.
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 | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor [G-CSF] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles. | 12 | 252 | 52 | 252 | 251 | 252 |
| EG001 | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles. | 14 | 248 | 49 | 248 | 248 | 248 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
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| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
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| Goitre | Endocrine disorders | MedDRA version 26.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Anal incontinence | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA version 26.0 | Systematic Assessment |
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| Death | General disorders | MedDRA version 26.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 26.0 | Systematic Assessment |
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| Lithiasis | General disorders | MedDRA version 26.0 | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA version 26.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 26.0 | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Escherichia bacteraemia | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Laryngopharyngitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Mastitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Neutropenic sepsis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Postoperative abscess | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Pseudomonas infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment |
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| Flap necrosis | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment |
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| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment |
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| Clostridium test positive | Investigations | MedDRA version 26.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
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| Periostitis | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
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| Angiosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
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| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
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| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
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| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
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| Gastric cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
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| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
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| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA version 26.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment |
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| Breast haematoma | Reproductive system and breast disorders | MedDRA version 26.0 | Systematic Assessment |
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| Breast inflammation | Reproductive system and breast disorders | MedDRA version 26.0 | Systematic Assessment |
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| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA version 26.0 | Systematic Assessment |
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| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA version 26.0 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
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| Embolism | Vascular disorders | MedDRA version 26.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA version 26.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 26.0 | Systematic Assessment |
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| Iliac artery occlusion | Vascular disorders | MedDRA version 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA version 26.0 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA version 26.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 26.0 | 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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 23, 2019 | Jun 3, 2020 | SAP_001.pdf |
| 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 |
|---|---|
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D000077143 | Docetaxel |
| D017239 | Paclitaxel |
| C485206 | pertuzumab |
| D000068878 | Trastuzumab |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 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
| Progressive Disease |
|
| Withdrawal by Subject |
|
| Other |
|
| Death |
|
| Physician Decision |
|
| Disease Relapse |
|
| Lost to Follow-up |
|
| 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 |
|
| ER Positive and PgR Positive |
|
| Unknown |
|
| Stage IIIB-IIIC |
|
| AC Followed by Docetaxel |
|
| OG001 | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles. |
|
|
|
| OG001 | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles. |
|
|
|
| OG001 | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles. |
|
|
|
| OG001 | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles. |
|
|
|
| OG001 | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles. |
|
|
|
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles. |
|
|
|
|
|
|
|
|
|
| OG001 | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles. |
|
|
| OG001 | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles. |
|
|
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles. |
|
|
| OG001 | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles. |
|
|
Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles. |
|
|
| OG001 | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles. |
|
|