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.
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
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There are 78 Locations for this study
Fullerton California, 92835, United States
Los Angeles California, 90095, United States
San Luis Obispo California, 93401, United States
Santa Maria California, 93454, United States
Santa Monica California, 90404, United States
Hollywood Florida, 33021, United States
Orlando Florida, 32806, United States
Scarborough Maine, 04074, United States
Henderson Nevada, 89052, United States
Bronx New York, 10467, United States
Lake Success New York, 11042, United States
Asheville North Carolina, 28806, United States
Charlotte North Carolina, 28204, United States
Charleston South Carolina, 29414, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Edegem , 2650, Belgium
Leuven , 3000, Belgium
Liège , 4000, Belgium
Namur , 5000, Belgium
Wilrijk , 2610, Belgium
Edmonton Alberta, T6G 1, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5B 1, Canada
Montreal Quebec, H2L 4, Canada
Montreal Quebec, H3T 1, Canada
Quebec , G1S 4, Canada
Angers , 49000, France
Besancon , 25030, France
Brest , 29200, France
La Roche Sur Yon , 85925, France
Lille , 59020, France
Marseille , 13009, France
Nantes , 44202, France
Saint Herblain , 44805, France
Strasbourg , 67091, France
Böblingen , 71032, Germany
Düsseldorf , 40235, Germany
Erlangen , 91054, Germany
Mainz , 55131, Germany
München , 80336, Germany
Gyeonggi-do , 10408, Korea, Republic of
Gyeonggi-do , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 6351, Korea, Republic of
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Kislino, Kursk Region , 30552, Russian Federation
Moscow , 11547, Russian Federation
Orenburg , 46002, Russian Federation
Saratov , 41000, Russian Federation
St Petersburg , 19702, Russian Federation
Sabadell Barcelona, 08208, Spain
San Sebastian Guipuzcoa, 20014, Spain
Lleida Lerida, 25198, Spain
Avila , 05071, Spain
Barcelona , 08003, Spain
Barcelona , 08006, Spain
Jaen , 23007, Spain
La Coruña , 15006, Spain
Madrid , 28007, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Madrid , 28223, Spain
Malaga , 29010, Spain
Sevilla , 41013, Spain
Valencia , 46010, Spain
Zaragoza , 50009, Spain
Kaohsiung , 807, Taiwan
Taipei City , 10041, Taiwan
Taipei City , 112, Taiwan
Taipei , 104, Taiwan
Taipei , 112, Taiwan
Taipei , 11490, Taiwan
Cherkassy , 18009, Ukraine
Dnipropetrovsk , 43102, Ukraine
Kharkiv , 61070, Ukraine
Lvov , 79031, Ukraine
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