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



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/20/2018
Start Date:June 30, 2014
End Date:May 29, 2018

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A Randomized, Multicenter, Open-Label, Two-Arm, Phase III Neoadjuvant Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Patients With HER2-Positive Breast Cancer

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.


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
We found this trial at
17
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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3700 Johnson Street
Hollywood, Florida 33021
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Hollywood, FL
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1400 South Orange Avenue
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
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Asheville, North Carolina 28816
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2095 Henry Tecklenburg Drive
Charleston, South Carolina 29414
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Charlotte, North Carolina 28211
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Charlotte, NC
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Edegem, 2650
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Edegem,
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2151 North Harbor Boulevard
Fullerton, California 92835
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Fullerton, CA
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Henderson, NV
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Houston, Texas 77030
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Houston, TX
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Lake Success, New York 11042
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757 Westwood Plaza
Los Angeles, California 90095
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Los Angeles, CA
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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San Luis Obispo, California 93401
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Santa Maria, California 93454
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Santa Monica, California 90404
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Scarborough, Maine 04074
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Scarborough, ME
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