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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004902-82 | EudraCT Number |
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This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Active Comparator | Trastuzumab and pertuzumab will be administered concurrently for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy. |
|
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Experimental | Trastuzumab emtansine and pertuzumab will continue for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab Emtansine | Drug | Trastuzumab emtansine IV infusion (duration 90 minutes) will be administered at 3.6 mg/kg q3w for up to 18 cycles (1 cycle = 21 days). |
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| Measure | Description | Time Frame |
|---|---|---|
| Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation | IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer [bc] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site [other than the three sites mentioned above]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population was estimated using the Kaplan-Meier method and estimated the probability of a participant being event-free after 3 years after randomization. | Last participant randomized to data cut-off date of 27 November 2019 (approximately 70 months). The 3 year IDFS event-free rate was assessed based on the data collected for each participant considering the cut-off date mentioned above. |
| Invasive Disease-Free Survival (IDFS) in the Overall Population | IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer [bc] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site [other than the three sites mentioned above]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization. | First participant randomized up to approximately 7.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| IDFS Plus Second Primary Non-Breast Cancer | IDFS including second primary non-breast cancer was defined the same way as IDFS for the primary endpoint but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ (CIS) of any site). | Baseline up to approximately 70 months |
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Inclusion Criteria:
Node-positive disease (pN more than or equal to [>/=] 1), any tumor size except T0, and any hormonal receptor status; or Node-negative disease (pN0) with pathologic tumor size >2.0 centimeters by standard local assessment and negative for estrogen receptor (ER) and progesterone receptor (PR) determined by a central pathology laboratory
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute - Bisgrove | Scottsdale | Arizona | 85258 | United States | ||
| Kaiser Permanente - Oakland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34890214 | Derived | Krop IE, Im SA, Barrios C, Bonnefoi H, Gralow J, Toi M, Ellis PA, Gianni L, Swain SM, Im YH, De Laurentiis M, Nowecki Z, Huang CS, Fehrenbacher L, Ito Y, Shah J, Boulet T, Liu H, Macharia H, Trask P, Song C, Winer EP, Harbeck N. Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: The Phase III KAITLIN Study. J Clin Oncol. 2022 Feb 10;40(5):438-448. doi: 10.1200/JCO.21.00896. Epub 2021 Dec 10. |
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Randomization was stratified according to geographic region, nodal status, centrally assessed hormonal receptor status and type of anthracycline.
The study was conducted at 288 centers in 36 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Trastuzumab and pertuzumab were administered concurrently for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jul 30, 2015 | Nov 17, 2020 |
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|
| Trastuzumab | Drug | Trastuzumab IV infusion (duration 90 minutes) will be administered at 8 mg/kg loading dose followed by 6 mg/kg IV q3w for up to 18 cycles (1 cycle = 21 days). |
|
|
| Pertuzumab | Drug | Pertuzumab infusion (duration 60 minutes) will be administered at 840 mg loading dose followed by 420 mg IV q3w for up to 18 cycles (1 cycle = 21 days). |
|
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| Paclitaxel | Drug | IV infusion of paclitaxel 80 mg/m^2 once weekly may be administered concurrently with trastuzumab in combination with pertuzumab for 12 weeks. |
|
| Epirubicin | Drug | 3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using epirubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines. |
|
| Doxorubicin | Drug | 3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using doxorubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines. |
|
| Docetaxel | Drug | IV infusion either docetaxel every 3 weeks (q3w) (at 100 milligram per square meter [mg/m^2] for 3 cycles (1 cycle = 21 days); at 75 mg/m2 for 4 cycles; or start at 75 mg/m^2 in the first cycle and escalate to 100 mg/m^2 if no dose limiting toxicity occurs, for a total of 3 cycles at minimum) may be administered concurrently with trastuzumab in combination with pertuzumab. |
|
| Cyclophosphamide | Drug | 3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using cyclophosphamide (FEC) may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines. |
|
| 5-Fluorouracil | Drug | 3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using 5-fluorouracil, may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines. |
|
| Disease-Free Survival (DFS) | DFS was defined as time between randomization and first occurrence of IDFS, second primary non-breast cancer and contralateral or ipsilateral ductal carcinoma in situ (DCIS). | Baseline up to approximately 70 months |
| Distant Recurrence-Free Interval (DRFI) | DRFI was defined as time between randomization and first occurrence of distant breast cancer recurrence. | Baseline up to approximately 70 months |
| Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. | First participant randomized up to approximately 7.5 years |
| Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). | From randomization to approximately 7.5 years |
| Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time | LVEF was assessed using either echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans. | First participant randomized up to approximately 7.5 years. |
| European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 7 - 15 points considered to be a clinically meaningful detioration to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1). | Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18 |
| EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30. There are four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated improvement in quality of life (QOL) while negative change from baseline indicated a deterioration. For symptom scales, positive change from baseline indicated deterioration and negative change indicated improvement. | Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18 |
| Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment | The time to clinically meaningful deterioration in the global health status/Quality of life and Functional (Physical, Role, and Cognitive) subscales of the the QLQ-C30 was assessed from the time of the HER2-Targeted treatment to the worsening in the respective scales. Clinically meaningful deterioration is defined as a decrease in score of 10 points in Physical functioning and HRQoL; decrease of 7 points in Cognitive functioning, and decrease of 14 points in Role functioning. | From start of HER-2 targeted treatment up to 18 months after treatment discontinuation. The median time to clinically meaningful deterioration was assessed based on the data collection described above. |
| Oakland |
| California |
| 94611 |
| United States |
| Kaiser Permanente - Roseville; Oncology Pharmacy | Roseville | California | 95661 | United States |
| Kaiser Permanente - Sacramento; Oncology Pharmacy | Sacramento | California | 95814 | United States |
| UC Davis Cancer Center; Oncology | Sacramento | California | 95817 | United States |
| Southern California Kaiser Permanente | San Diego | California | 92108 | United States |
| Kaiser Permanente - San Jose | San Jose | California | 95119 | United States |
| Kaiser Permanente - San Leandro | San Leandro | California | 94577 | United States |
| Kaiser Permanente - South SF; Oncology Clinical trials | South San Francisco | California | 94080 | United States |
| Stanford University School of Medicine | Stanford | California | 94305-5151 | United States |
| Kaiser Permanente - Vallejo | Vallejo | California | 94589 | United States |
| Kaiser Permanente - Walnut Creek; Oncology Pharmacy | Walnut Creek | California | 94596 | United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| Florida Cancer Specialists; SCRI | Fort Myers | Florida | 33901 | United States |
| Florida Cancer Specialists; Saint Petersburg | St. Petersburg | Florida | 33719 | United States |
| University Cancer & Blood Center, LLC; Research | Athens | Georgia | 30607 | United States |
| Georgia Cancer Specialists | Atlanta | Georgia | 30341 | United States |
| Central Georgia Cancer Care PC | Macon | Georgia | 31201 | United States |
| Quincy Medical Group; Canc Ctr at Blessing Hosp | Quincy | Illinois | 62301 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214-3728 | United States |
| Anne Arundel Health System Research Instit-Annapolis Oncology Ctr | Annapolis | Maryland | 21401 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Dana Farber Cancer Inst. | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Med Ctr | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute.. | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital; Hematology Oncology | Detroit | Michigan | 48202 | United States |
| US oncology research at Minnesota Oncology | Saint Paul | Minnesota | 55102 | United States |
| Mercy Medical Research Institute | Springfield | Missouri | 65807 | United States |
| Dartmouth Hitchcock Med Center | Lebanon | New Hampshire | 03756 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Memorial Sloan-Kettering Cancer Center | Commack | New York | 11725 | United States |
| ProHEALTH Care Associates LLP | Lake Success | New York | 11042 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cone Health Cancer Center | Greensboro | North Carolina | 27403 | United States |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | United States |
| Mercy Clinic Oklahoma Communties, Inc | Oklahoma City | Oklahoma | 73120 | United States |
| Magee-Woman's Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| SCRI Tennessee Oncology Chattanooga | Chattanooga | Tennessee | 37404 | United States |
| West Clinic | Germantown | Tennessee | 38138 | United States |
| Thompson Cancer Survival Center | Knoxville | Tennessee | 37916-2305 | United States |
| Sarah Cannon Cancer Center - Tennessee Oncology, Pllc | Nashville | Tennessee | 37203 | United States |
| The Center for Cancer and Blood Disorders - Fort Worth | Fort Worth | Texas | 76104 | United States |
| Wellmont Medical Associates | Bristol | Virginia | 24201 | United States |
| University of Virginia Health System; Hematology/Oncology Division | Charlottesville | Virginia | 22908 | United States |
| Virginia Commonwealth University - Massey Cancer Center | Richmond | Virginia | 23298 | United States |
| Blue Ridge Cancer Care - Salem | Salem | Virginia | 24153 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| Calvary Mater Newcastle; Medical Oncology | Waratah | New South Wales | 2298 | Australia |
| Haematology & Oncology Clinics of Australia Research Centre | South Brisbane | Queensland | 4101 | Australia |
| Burnside War Memorial Hospital, Clinical Trials Centre | Adelaide | South Australia | 5056 | Australia |
| Frankston Hospital; Oncology/Haematology | Frankston | Victoria | 3199 | Australia |
| Austin Hospital; Medical Oncology | Heidelberg | Victoria | 3084 | Australia |
| Epworth HealthCare; Clinical Trials Centre | Richmond | Victoria | 3121 | Australia |
| St John of God Murdoch Hospital; Oncology West | Murdoch | Western Australia | 6150 | Australia |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Sint Augustinus Wilrijk, Apotheek | Wilrijk | 2610 | Belgium |
| University Clinical Center of the Republic of Srpska | Banja Luka | 78000 | Bosnia and Herzegovina |
| Clinic of Oncology, University Clinical Center Sarajevo | Sarajevo | 7100 | Bosnia and Herzegovina |
| Hospital Araujo Jorge; Departamento de Ginecologia E Mama | Goiânia | Goiás | 74605-070 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Hospital de Cancer de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Hospital Sirio Libanes; Centro de Oncologia | São Paulo | São Paulo | 01308-050 | Brazil |
| Hospital Perola Byington | São Paulo | São Paulo | 01317-000 | Brazil |
| Hospital Paulistano | São Paulo | São Paulo | 01321-000 | Brazil |
| Tom Baker Cancer Centre-Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre) | Kelowna | British Columbia | V1Y 5L3 | Canada |
| Lions Gate Hospital | North Vancouver | British Columbia | V7L 2L7 | Canada |
| BCCA-Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Regional health authority A vitalite health network | Moncton | New Brunswick | E1C 8X3 | Canada |
| Queen Elizabeth II Health Sciences Centre; Oncology | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre | Mississauga | Ontario | L5M 2N1 | Canada |
| Southlake Regional Health Center; Community Care Clinic / Oncology | Newmarket | Ontario | L3Y 2P9 | Canada |
| Lakeridge Health Oshawa; Oncology | Oshawa | Ontario | L1G 2B9 | Canada |
| Sault Area Hospital | Sault Ste. Marie | Ontario | P6B 0A8 | Canada |
| North York General Hospital | Toronto | Ontario | M2J 1V1 | Canada |
| Princess Margaret Cancer Center | Toronto | Ontario | M5G 1Z5 | Canada |
| Windsor Regional Cancer Centre | Windsor | Ontario | N8W 2X3 | Canada |
| Cite de La Sante de Laval; Hemato-Oncologie | Laval | Quebec | H7M 3L9 | Canada |
| McGill University; Glen Site; Oncology | Montreal | Quebec | H4A 3J1 | Canada |
| Hopital du Saint Sacrement | Québec | Quebec | G1S 4L8 | Canada |
| Instituto Oncologico del sur | Temuco | 4810469 | Chile |
| ONCOCENTRO APYS; Oncología | Viña del Mar | 2520598 | Chile |
| Oncomedica S.A. | Montería | 230002 | Colombia |
| Masarykuv onkologicky ustav | Brno | 656 53 | Czechia |
| Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology | Hradec Králové | 500 05 | Czechia |
| MULTISCAN, s.r.o., Radiologicke centrum Pardubice | Pardubice | 532 03 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Hospital Diagnostico Escalón | San Salvador | 01101 | El Salvador |
| Ico - Paul Papin | Angers | 49000 | France |
| Clinique Sainte Catherine | Avignon | 84082 | France |
| HOPITAL JEAN MINJOZ; Oncologie | Besançon | 25030 | France |
| Institut Bergonie; Oncologie | Bordeaux | 33076 | France |
| CHU de Brest - Hôpital de Morvan | Brest | 29609 | France |
| Centre Francois Baclesse; Oncologie | Caen | 14076 | France |
| Centre Jean Perrin; Oncologie | Clermont-Ferrand | 63011 | France |
| Centre Georges Francois Leclerc; Oncologie 3 | Dijon | 21079 | France |
| 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 |
| Centre D'Oncologie de Gentilly; Oncology | Nancy | 54100 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Institut de cancerologie du Gard | Nîmes | 30029 | France |
| HOPITAL TENON; Cancerologie Medicale | Paris | 75970 | France |
| Centre Armoricain de Radiotherapie, de Imagerie Medicale et de Oncologie (CARIO) | Plérin | 22190 | France |
| Polyclinique De Courlancy; Centre Radiotherapie Oncologie | Reims | 51057 | France |
| Centre Eugene Marquis; Service d'oncologie | Rennes | 35042 | France |
| Ico Rene Gauducheau; Oncologie | Saint-Herblain | 44805 | France |
| Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0 | Saint-Priest-en-Jarez | 42271 | France |
| Institut d'oncologie de l'Orangerie; Chimiotherapie | Strasbourg | 67010 | France |
| Centre Paul Strauss; Oncologie Medicale | Strasbourg | 67065 | France |
| Institut Claudius Regaud; Departement Oncologie Medicale | Toulouse | 31059 | France |
| Centre Alexis Vautrin; Oncologie Medicale | Vandœuvre-lès-Nancy | 54519 | France |
| LTD Institute of Clinical Oncology | Tbilisi | 0159 | Georgia |
| Khechinashvili University Hospital ;Breast Unit | Tbilisi | 0177 | Georgia |
| Chemotherapy and Immunotherapy Clinic Medulla | Tbilisi | 0186 | Georgia |
| Klinikum Augsburg | Augsburg | 86156 | Germany |
| Hochwaldkrankenhaus | Bad Nauheim | 61231 | Germany |
| Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche | Berlin | 14169 | Germany |
| Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel | Bochum | 44787 | Germany |
| Praxis Dr.med. Katja Ziegler-Löhr | Cologne | 50679 | Germany |
| BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie | Dresden | 01307 | Germany |
| AGAPLESION Markus-Krankenhaus | Frankfurt | 60431 | Germany |
| Städtische Kliniken Frankfurt am Main Höchst | Frankfurt | 65929 | Germany |
| Praxis für Interdisziplinäre Onkologie und Hämatologie GbR | Freiburg im Breisgau | 79110 | Germany |
| Dres.Jochen Wilke und Harald Wagner | Fürth | 90766 | Germany |
| Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH | Georgsmarienhütte | 49124 | Germany |
| Universitätsklinikum Hamburg-Eppendorf; Frauenklinik | Hamburg | 20246 | Germany |
| Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding | Hanover | 30177 | Germany |
| Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe | Hanover | 30625 | Germany |
| Klinikum Kulmbach; Frauenklinik | Kulmbach | 95326 | Germany |
| Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe | Lübeck | 23538 | Germany |
| Klinikum Meiningen Klinik f.Gynäkologie und Geburtshilfe | Meiningen | 98617 | Germany |
| Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde | München | 81377 | Germany |
| Hämatologisch/Onkologische Praxis Prof. Dr. Decker, Studienzentrum | Ravensburg | 88212 | Germany |
| Agaplesion Diakonieklinikum Rotenburg | Rotenburg (Wümme) | 27356 | Germany |
| Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher | Stralsund | 18439 | Germany |
| Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis | Troisdorf | 53840 | Germany |
| GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe | Weinheim | 69469 | Germany |
| Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe | Worms | 67550 | Germany |
| Centro Oncológico Sixtino / Centro Oncológico SA | Guatemala City | 01010 | Guatemala |
| Grupo Angeles | Guatemala City | 01015 | Guatemala |
| Princess Margaret Hospital; Oncology | Hong Kong | Hong Kong |
| Tuen Mun Hospital; Clinical Oncology | Hong Kong | Hong Kong |
| Queen Mary Hospital; Dept of Surgery | Pokfulam | Hong Kong |
| Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly | Budapest | 1122 | Hungary |
| Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology | Budapest | 1145 | Hungary |
| Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika | Debrecen | 4032 | Hungary |
| Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika | Szeged | 6720 | Hungary |
| Chaim Sheba Medical Center; Oncology Dept | Ramat Gan | 5262100 | Israel |
| Sourasky / Ichilov Hospital; Oncology Department | Tel Aviv | 64239-06 | Israel |
| Ospedale Antonio Perrino; Oncologia Medica | Brindisi | Apulia | 72100 | Italy |
| Istituto Nazionale Tumori Fondazione G. Pascale | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica | Bologna | Emilia-Romagna | 40138 | Italy |
| Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica | Aviano | Friuli Venezia Giulia | 33081 | Italy |
| Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica | Rome | Lazio | 00128 | Italy |
| Istituto Nazionale Tumori Regina Elena IRCCS | Rome | Lazio | 00144 | Italy |
| ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit | Cremona | Lombardy | 26100 | Italy |
| Ospedale San Raffaele | Milan | Lombardy | 20132 | Italy |
| Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1 | Milan | Lombardy | 20133 | Italy |
| ASST DI MONZA; Oncologia Medica | Monza | Lombardy | 20900 | Italy |
| Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia | Rozzano | Lombardy | 20089 | Italy |
| Humanitas Centro Catanese Di Oncologia; Oncologia Medica | Misterbianco (CT) | Sicily | 95045 | Italy |
| Ospedale Misericordia E Dolce; Oncologia Medica | Prato | Tuscany | 59100 | Italy |
| Azienda Ospedaliera S. Maria - Terni; Oncologia | Terni | Umbria | 05100 | Italy |
| IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II | Padova | Veneto | 35128 | Italy |
| Aichi Cancer Center Hospital, Breast Oncology | Aichi | 464-8681 | Japan |
| Nagoya City University Hospital; Breast Surgery | Aichi | 467-8602 | Japan |
| Natl Hosp Org Shikoku; Cancer Ctr, Surgery | Ehime | 791-0280 | Japan |
| National Hospital Organization Kyushu Cancer Center;Breast Oncology | Fukuoka | 811-1395 | Japan |
| Gunma University Hospital; Department of Breast and Endocrine Surgery | Gunma | 371-8511 | Japan |
| Gunma Prefectural Cancer Center; Breast Oncology | Gunma | 373-8550 | Japan |
| Hiroshima City Hiroshima Citizens Hospital; Breast Surgery | Hiroshima | 730-8518 | Japan |
| Hiroshima University Hospital; Breast Surgery | Hiroshima | 734-8551 | Japan |
| Hyogo College Of Medicine; Breast And Endocrine Surgery | Hyōgo | 663-8501 | Japan |
| Sagara Hospital; Breast Surgery | Kagoshima | 892-0833 | Japan |
| St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery | Kanagawa | 216-8511 | Japan |
| Tokai University Hospital, Breast Surgery | Kanagawa | 259-1193 | Japan |
| Kumamoto City Hospital, Breast and Endocrine Surgery | Kumamoto | 862-8505 | Japan |
| Kumamoto Shinto General Hospital; Breast Cancer Center | Kumamoto | 862-8655 | Japan |
| Kyoto University Hospital; Breast Surgery | Kyoto | 606-8507 | Japan |
| Niigata Cancer Ctr Hospital; Breast Surgery | Niigata | 951-8566 | Japan |
| Iwate Med Univ School of Med; Surgery | Numakunai | 028-3695 | Japan |
| Kawasaki Medical School Hospital; Breast and Thyroid Surgery | Okayama | 701-0114 | Japan |
| Naha-nishi Clinic; Surgery | Okinawa | 901-0154 | Japan |
| National Hospital Organization Osaka National Hospital; Breast Surgery | Osaka | 540-0006 | Japan |
| Osaka International Cancer Institute; Breast and Endocrine Surgery | Osaka | 541-8567 | Japan |
| Saitama Medical University International Medical Center; Breast Oncology | Saitama | 350-1298 | Japan |
| Saitama Cancer Center, Breast Oncology | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center; Breast Surgery | Shizuoka | 411-8777 | Japan |
| Shizuoka General Hospital; Breast Surgery | Shizuoka | 420-8527 | Japan |
| Jichi Medical University; Breast Oncology | Tochigi | 329-0498 | Japan |
| National Cancer Center Hospital; Medical Oncology | Tokyo | 104-0045 | Japan |
| St. Luke's Internat. Hospital, Breast Surgical Oncology | Tokyo | 104-8560 | Japan |
| Tokyo Metropolitan; Komagome Hospital, Surgery | Tokyo | 113-8677 | Japan |
| The Cancer Inst. Hosp. of JFCR; Breast Oncology Center | Tokyo | 135-8550 | Japan |
| Showa University Hospital; Breast Surgery | Tokyo | 142-8666 | Japan |
| Tokyo Medical Uni. Hospital; Breast Oncology | Tokyo | 160-0023 | Japan |
| Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios | Distrito Federal | 14000 | Mexico |
| Fundacion Rodolfo Padilla Padilla A.C. | León | 37000 | Mexico |
| Consultorio de Medicina Especializada; Dentro de Condominio San Francisco | Mexico City | 03100 | Mexico |
| Hospital San Jose Del Tec. de Monterrey; Oncology | Monterrey | 64020 | Mexico |
| Oslo universitetssykehus HF, Ullevål, Kreftsenteret | Oslo | 0450 | Norway |
| Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer | Stavanger | 4011 | Norway |
| Centro Hemato Oncologico Panama | Panama City | 0832 | Panama |
| Clinica de Especialidades Medicas | Lima | Lima 41 | Peru |
| Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional | Lima | Lima 41 | Peru |
| Clinica San Borja | Lima | Lima 41 | Peru |
| Instituto Oncologico Miraflore | Miraflores | Lima 18 | Peru |
| San Juan de Dios Hospital;Oncology Unit | Pasay | 1300 | Philippines |
| East Avenue Medical Center | Quezon City | 1100 | Philippines |
| Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej | Bialystok | 15-027 | Poland |
| Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii | Bydgoszcz | 85-796 | Poland |
| Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii | Gdansk | 80-214 | Poland |
| Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii | Krakow | 30-688 | Poland |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; Poradnia Chemioterapii | Lodz | 93-513 | Poland |
| Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii | Lublin | 20-090 | Poland |
| Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii | Otwock | 05-400 | Poland |
| Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr | Warsaw | 02-781 | Poland |
| Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti | Bucharest | 022328 | Romania |
| Cluj Clinical County Hospital; Oncology Dept | Cluj-Napoca | 400006 | Romania |
| Prof. Dr. I. Chiricuta Institute of Oncology | Cluj-Napoca | 400015 | Romania |
| Regional Institute of Oncology Iasi | Iași | 700483 | Romania |
| Ivanovo Regional Oncology Dispensary | Ivanovo | 153040 | Russia |
| Republican Clinical Oncologic Dispensary of Republic Of Tatarstan | Kazan' | 420029 | Russia |
| FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF | Moscow | 115478 | Russia |
| State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis | Orenburg | 460021 | Russia |
| SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF | Ryazan | 390011 | Russia |
| Scientific Research Institute n.a. N.N. Petrov | Saint Petersburg | 197758 | Russia |
| SBI of Healthcare Samara Regional Clinical Oncology Dispensary | Samara | 443031 | Russia |
| National University Hospital; National University Cancer Institute, Singapore (NCIS) | Singapore | 119228 | Singapore |
| National Cancer Centre; Medical Oncology | Singapore | 169610 | Singapore |
| National Cancer Center; Medical Oncology | Gyeonggi-do | 410-769 | South Korea |
| Ajou Uni Hospital; Medical Oncology | Gyeonggi-do | 443-380 | South Korea |
| Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Samsung Medical Centre; Division of Hematology/Oncology | Seoul | 135-710 | South Korea |
| Hospital Universitario de Canarias;servicio de Oncologia | San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Hospital de Cruces; Servicio de Oncologia | Bilbao | Vizcaya | 48903 | Spain |
| Hospital del Mar; Servicio de Oncologia | Barcelona | 08003 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| Hospital Duran i Reynals; Oncologia | Barcelona | 08907 | Spain |
| Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | 28007 | Spain |
| Centro Oncologico MD Anderson Internacional; Servicio de Oncologia | Madrid | 28033 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia | Málaga | 29010 | Spain |
| Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia | Murcia | 30120 | Spain |
| Hospital Clínico Universitario de Valencia; Servicio de Oncología | Valencia | 46010 | Spain |
| Hospital Universitario Miguel Servet; Servicio Oncologia | Zaragoza | 50009 | Spain |
| Sahlgrenska Universitetssjukhuset; Jubileumskliniken | Gothenburg | 413 45 | Sweden |
| Universitetssjukhuset Örebro, Onkologiska kliniken | Örebro | 701 85 | Sweden |
| Akademiska sjukhuset, Onkologkliniken | Uppsala | 751 85 | Sweden |
| Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie | Chur | 7000 | Switzerland |
| Luzerner Kantonsspital; Medizinische Onkologie | Lucerne | 6004 | Switzerland |
| Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich | Zurich | 8008 | Switzerland |
| Changhua Christian Hospital; Dept of Surgery | Changhua | 500 | Taiwan |
| Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery | Kaohsiung City | 807 | Taiwan |
| Taichung Veterans General Hospital; Dept of Surgery | Taichung | 407 | Taiwan |
| VETERANS GENERAL HOSPITAL; Department of General Surgery | Taipei | 00112 | Taiwan |
| National Taiwan Uni Hospital; General Surgery | Taipei | 100 | Taiwan |
| Tri-Service General Hospital, Division of General Surgery | Taipei | 114 | Taiwan |
| Chulalongkorn Hospital; Medical Oncology | Bangkok | 10330 | Thailand |
| Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology | Bangkok | 10700 | Thailand |
| Chiang Rai Prachanukroh Hospital; Department Of Medicine | Chiang Rai | 57000 | Thailand |
| Buddhachinaraj Phitsanulok Hospital; Chemotherapy Unit ; Department of Medicine | Phitsanuok | 65000 | Thailand |
| State Medical Academy; Oncology | Dnipropetrovsk | 43102 | Ukraine |
| Lviv State Oncological Regional Treatment and Diagnostic Center | Lviv | 79031 | Ukraine |
| Velindre Cancer Centre; Oncology Dept | Cardiff | CF14 2TL | United Kingdom |
| Cheltenham General Hospital; Gloucestershire Oncology Centre | Cheltenham | GL53 7AN | United Kingdom |
| Royal Cornwall Hospital; Dept of Clinical Oncology | Cornwall | TR1 3LQ | United Kingdom |
| University Hospital Coventry; InHANSE Unit and Clinical Trials Cancer Treatment Centre | Coventry | CV2 2DX | United Kingdom |
| Western General Hospital; Edinburgh Breast Unit | Edinburgh | EH4 2XU | United Kingdom |
| Royal Devon & Exeter Hospital; Oncology Centre | Exeter | EX2 5DW | United Kingdom |
| Royal Surrey County Hospital; St. Lukes Cancer Centre | Guildford | GU2 7XX | United Kingdom |
| Leicester Royal Infirmary; Dept. of Medical Oncology | Leicester | LE1 5WW | United Kingdom |
| Royal Marsden Hospital - Fulham; Oncology Department | London | SW3 6JJ | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| Maidstone Hospital; Kent Oncology Centre | Maidstone | ME16 9QQ | United Kingdom |
| Christie Hospital; Breast Cancer Research Office | Manchester | M20 4QL | United Kingdom |
| Freeman Hospital; Northern Centre For Cancer Care | New Castle Upon Tyne | NE7 7DN | United Kingdom |
| Mount Vernon Cancer Centre | Northwood | HA6 2RN | United Kingdom |
| Nottingham City Hospital; Oncology | Nottingham | NG5 1PB | United Kingdom |
| Peterborough City Hospital, Edith Cavell Campus; Oncology Department | Peterborough | PE3 9GZ | United Kingdom |
| Queen Alexandra Hospital; Portsmouth Haematology & Oncology Centre, Level B | Portsmouth | PO6 3LY | United Kingdom |
| Weston Park Hospital; Cancer Clinical Trials Centre | Sheffield | S10 2SJ | United Kingdom |
| Musgrove Park Hospital; Department Clinical Research, Beacon Centre | Somerset | TA1 5DA | United Kingdom |
| Uni Hospital of North Staffordshire; Staffordshire Oncology Centre | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Royal Marsden Hospital; Dept of Medical Oncology | Sutton | SM2 5PT | United Kingdom |
| Yeovil District Hospital; Macmillan Cancer Unit | Yeovil | BA21 4AT | United Kingdom |
| FG001 | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline Measures are based on the Intent-to-Treat (ITT) population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Trastuzumab and pertuzumab were administered concurrently for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy. |
| BG001 | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation | IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer [bc] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site [other than the three sites mentioned above]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population was estimated using the Kaplan-Meier method and estimated the probability of a participant being event-free after 3 years after randomization. | The ITT lymph node positive population was a subpopulation of the randomized participant population including patients with positive lymph node. | Posted | Number | 95% Confidence Interval | Percent Probability | Last participant randomized to data cut-off date of 27 November 2019 (approximately 70 months). The 3 year IDFS event-free rate was assessed based on the data collected for each participant considering the cut-off date mentioned above. |
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| Primary | Invasive Disease-Free Survival (IDFS) in the Overall Population | IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer [bc] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site [other than the three sites mentioned above]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization. | The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment. | Posted | Number | 95% Confidence Interval | Percent Probability | First participant randomized up to approximately 7.5 years |
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| Secondary | IDFS Plus Second Primary Non-Breast Cancer | IDFS including second primary non-breast cancer was defined the same way as IDFS for the primary endpoint but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ (CIS) of any site). | The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment. | Posted | Number | 95% Confidence Interval | Percent Probability | Baseline up to approximately 70 months |
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| Secondary | Disease-Free Survival (DFS) | DFS was defined as time between randomization and first occurrence of IDFS, second primary non-breast cancer and contralateral or ipsilateral ductal carcinoma in situ (DCIS). | The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment. | Posted | Number | 95% Confidence Interval | Percent Probability | Baseline up to approximately 70 months |
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| Secondary | Distant Recurrence-Free Interval (DRFI) | DRFI was defined as time between randomization and first occurrence of distant breast cancer recurrence. | Posted | Number | 95% Confidence Interval | Percent Probability | Baseline up to approximately 70 months |
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| Secondary | Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. | The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment. | Posted | Number | 95% Confidence Interval | Percent Probability | First participant randomized up to approximately 7.5 years |
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| Secondary | Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). | The safety population included all randomized participants who received at least one full or partial dose of any study treatment. 8 participants were randomized but did not receive any study treatment (5 in the Anthracycline, Trastuzumab, Pertuzumab, and Taxane [AC-THP] arm, 3 in the Anthracycline, Trastuzumab Emtansine and Pertuzumab [AC-KP] arm). 16 participants in the AC-THP and 13 participants in the AC-KP arm only received AC but no HER2 targeted therapy and were assigned to the AC-THP arm. | Posted | Number | Percentage of participants | From randomization to approximately 7.5 years |
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| Secondary | Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time | LVEF was assessed using either echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans. | The safety population included all randomized participants who received at least one full or partial dose of any study treatment. | Posted | Count of Participants | Participants | First participant randomized up to approximately 7.5 years. |
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| Secondary | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 7 - 15 points considered to be a clinically meaningful detioration to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1). | The Patient Reported Outcome (PRO) Population includes participants with both a baseline assessment and at least one post-baseline assessment in any PRO items. The variation of the number of participants in the table reflects the number of participants with corresponding scores at the given visits and at baseline. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18 |
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| Secondary | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30. There are four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated improvement in quality of life (QOL) while negative change from baseline indicated a deterioration. For symptom scales, positive change from baseline indicated deterioration and negative change indicated improvement. | The Patient Reported Outcome (PRO) Population includes participants with both a baseline assessment and at least one post-baseline assessment in any PRO items. The variation of the number of participants in the table reflects the number of participants with corresponding scores at the given visits and at baseline. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18 |
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| Secondary | Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment | The time to clinically meaningful deterioration in the global health status/Quality of life and Functional (Physical, Role, and Cognitive) subscales of the the QLQ-C30 was assessed from the time of the HER2-Targeted treatment to the worsening in the respective scales. Clinically meaningful deterioration is defined as a decrease in score of 10 points in Physical functioning and HRQoL; decrease of 7 points in Cognitive functioning, and decrease of 14 points in Role functioning. | The Patient Reported Outcome (PRO) Population includes participants with both a baseline assessment and at least one post-baseline assessment in any PRO items. This subset population includes only participants who received HER2-targeted therapy. | Posted | Median | 95% Confidence Interval | months | From start of HER-2 targeted treatment up to 18 months after treatment discontinuation. The median time to clinically meaningful deterioration was assessed based on the data collection described above. |
|
From randomization to approximately 7.5 years
AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0. 8 participants were randomized but did not receive any study treatment (5 in the AC-THP arm, 3 in the AC-KP arm). 16 participants in the AC-THP, and 13 in the AC-KP arm only received AC but no HER2 targeted therapy and were consequently assigned to the AC-THP arm for safety analysis.
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 | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Trastuzumab and pertuzumab were administered concurrently for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy. | 45 | 926 | 216 | 926 | 902 | 926 |
| EG001 | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy. | 55 | 912 | 195 | 912 | 902 | 912 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
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| Congestive cardiomyopathy | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
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| Left ventricular dysfunction | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
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| Hypoacusis | Ear and labyrinth disorders | MedDRA version 24.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Diverticulum | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Duodenal perforation | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Duodenal ulcer | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Gastric haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Catheter site vesicles | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Medical device pain | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Nodular regenerative hyperplasia | Hepatobiliary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Portal hypertension | Hepatobiliary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Breast cellulitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Chest wall abscess | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Gastrointestinal bacterial infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Incision site abscess | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Infected seroma | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Inflammation of wound | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Electrocardiogram repolarisation abnormality | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| N-terminal prohormone brain natriuretic peptide increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0 | Systematic Assessment |
| |
| Acute promyelocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0 | Systematic Assessment |
| |
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0 | Systematic Assessment |
| |
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0 | Systematic Assessment |
| |
| Haemangioma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0 | Systematic Assessment |
| |
| Uterine leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA version 24.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Breast necrosis | Reproductive system and breast disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Fibrocystic breast disease | Reproductive system and breast disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Uterine cyst | Reproductive system and breast disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Spider naevus | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA version 24.0 | 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 | Jan 17, 2020 | Nov 17, 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 |
|---|---|
| D000080044 | Ado-Trastuzumab Emtansine |
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| D017239 | Paclitaxel |
| D015251 | Epirubicin |
| D004317 | Doxorubicin |
| D000077143 | Docetaxel |
| D003520 | Cyclophosphamide |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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 | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy. |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| OG001 | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy. |
|
|
| OG001 | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy. |
|
|
| OG001 | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy. |
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