Breast Cancer Clinical Trial

A Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

Summary

This is a randomized, multicenter, open-label, two-arm study in treatment-naive participants with operable, locally advanced, or inflammatory, centrally-assessed HER2-positive early breast cancer (EBC) whose primary tumors were greater than or equal to (>/=) 2 centimeters (cm). The study was designed to evaluate the efficacy and safety of trastuzumab emtansine + pertuzumab (experimental arm; T-DM1 + P) versus chemotherapy, trastuzumab + pertuzumab (control arm; TCH + P). The study comprised a neoadjuvant treatment period, followed by surgery, and an adjuvant treatment period.

Treatment can be stopped due to disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed invasive breast cancer with a primary tumor size of greater than (>) 2 cm
HER2-positive breast cancer
Participants with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) are eligible provided all discrete lesions are sampled and centrally confirmed as HER2 positive
Stage at presentation: cT2-cT4, cN0-cN3, cM0, according to American Joint Committee on Cancer (AJCC) staging system
Known hormone receptor status of the primary tumor
Participant agreement to undergo mastectomy or breast-conserving surgery after neoadjuvant therapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Baseline Left Ventricular Ejection Fraction (LVEF) >/= 55 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA)
Effective contraception as defined by protocol

Exclusion Criteria:

Stage IV (metastatic) breast cancer
Participants who have received prior anti-cancer therapy for breast cancer except those participants with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated exclusively with mastectomy. In case of prior history of LCIS/DCIS, >5 years must have passed from surgery until diagnosis of current breast cancer
Participants with multicentric (multiple tumors involving more than 1 quadrant) or bilateral breast cancer
Participants who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
Axillary lymph node dissection or positive sentinel lymph node prior to start of neoadjuvant therapy
History of concurrent or previously non-breast malignancies except for appropriately treated (1) non-melanoma skin cancer and (2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease-free >/= 5 years
Treatment with any investigational drug within 28 days prior to randomization
Current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0
Any significant concurrent medical or surgical conditions or findings that would jeopardize the participant's safety or ability to complete the study
Current pregnancy or breastfeeding

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

444

Study ID:

NCT02131064

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 78 Locations for this study

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St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
Fullerton California, 92835, United States
Cancer Care Assoc Med Group
Los Angeles California, 90095, United States
Coastal Integrative Cancer Care
San Luis Obispo California, 93401, United States
Central Coast Medical Oncology
Santa Maria California, 93454, United States
UCLA Hematology/Oncology
Santa Monica California, 90404, United States
Memorial Cancer Institute
Hollywood Florida, 33021, United States
Md Anderson Cancer Center Orlando
Orlando Florida, 32806, United States
New England Cancer Specialists
Scarborough Maine, 04074, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson Nevada, 89052, United States
Montefiore Medical Center
Bronx New York, 10467, United States
ProHEALTH Care Associates LLP
Lake Success New York, 11042, United States
Hope A Women's Cancer Center
Asheville North Carolina, 28806, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Roper Bon Secours St. Francis Cancer Center
Charleston South Carolina, 29414, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
UZ Antwerpen
Edegem , 2650, Belgium
UZ Leuven Gasthuisberg
Leuven , 3000, Belgium
Clinique Saint-Joseph
Liège , 4000, Belgium
Clinique Ste-Elisabeth, Pharmacie
Namur , 5000, Belgium
Sint Augustinus Wilrijk
Wilrijk , 2610, Belgium
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton Alberta, T6G 1, Canada
Sunnybrook Health Sciences Centre
Toronto Ontario, M4N 3, Canada
St. Michael'S Hospital
Toronto Ontario, M5B 1, Canada
Chum Hospital Notre Dame
Montreal Quebec, H2L 4, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal Quebec, H3T 1, Canada
CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY
Quebec , G1S 4, Canada
Ico - Paul Papin
Angers , 49000, France
HOPITAL JEAN MINJOZ; Oncologie
Besancon , 25030, France
Hopital Morvan
Brest , 29200, France
CHD Les Oudairies
La Roche Sur Yon , 85925, France
Centre Oscar Lambret
Lille , 59020, France
Institut Paoli Calmettes
Marseille , 13009, France
Centre Catherine De Sienne
Nantes , 44202, France
Centre Rene Gauducheau
Saint Herblain , 44805, France
Nouvel Hopital Civil - CHU Strasbourg
Strasbourg , 67091, France
Klinikum Sindelfingen-Böblingen; Frauenklinik
Böblingen , 71032, Germany
Luisenkrankenhaus GmbH, Brustzentrum
Düsseldorf , 40235, Germany
Universitätsklinikum Erlangen; Frauenklinik
Erlangen , 91054, Germany
Universitätsklinikum Mainz
Mainz , 55131, Germany
Interdisziplinäres Onkologisches Zentrum
München , 80336, Germany
National Cancer Center
Gyeonggi-do , 10408, Korea, Republic of
Seoul National University Bundang Hospital
Gyeonggi-do , 13620, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital
Seoul , 03722, Korea, Republic of
Asan Medical Center - Oncology
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 6351, Korea, Republic of
Moscow City Oncology Hospital #62
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Regional Oncology Hospital Of Kursk; Chemotherapy
Kislino, Kursk Region , 30552, Russian Federation
S.I. Russian Oncological Research Center n.a. N.N. Blokhin
Moscow , 11547, Russian Federation
State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis
Orenburg , 46002, Russian Federation
Railway Clinical Hospital on Saratov - 2 Station Oao "Rzhd"
Saratov , 41000, Russian Federation
Saint-Petersburg City Clinical Oncology Dispensary
St Petersburg , 19702, Russian Federation
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell Barcelona, 08208, Spain
IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia
San Sebastian Guipuzcoa, 20014, Spain
Hospital Universitari de Lleida Arnau de Vilanova
Lleida Lerida, 25198, Spain
Hospital Nuestra Señora de Sonsoles; servicio de Oncologia
Avila , 05071, Spain
Hospital del Mar; Servicio de Oncologia
Barcelona , 08003, Spain
Fundacio Santa Creu I Sant Pau
Barcelona , 08006, Spain
Complejo Hospitalario de Jaen
Jaen , 23007, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
La Coruña , 15006, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid , 28007, Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid , 28040, Spain
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
Madrid , 28050, Spain
Hospital Quiron de Madrid; Servicio de Oncologia
Madrid , 28223, Spain
Hospital Universitario Virgen de la Victoria
Malaga , 29010, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza , 50009, Spain
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
Kaohsiung , 807, Taiwan
National Taiwan Uni Hospital
Taipei City , 10041, Taiwan
Taipei Veterans General Hospital
Taipei City , 112, Taiwan
Mackay Memorial Hospital; Dept of Surgery
Taipei , 104, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Taipei , 112, Taiwan
Tri-Service General Hospital
Taipei , 11490, Taiwan
Cherkassy Regional Oncological Hospital
Cherkassy , 18009, Ukraine
State Medical Academy; Oncology
Dnipropetrovsk , 43102, Ukraine
Karkiv Regional Oncology Center
Kharkiv , 61070, Ukraine
Lvov State Regional Center
Lvov , 79031, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

444

Study ID:

NCT02131064

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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