A Study of Pertuzumab in Addition to Chemotherapy and Herceptin (Trastuzumab) as Adjuvant Therapy in Patients With HER2-Positive Primary Breast Cancer
Basic Trial Information
|Phase III||Treatment||Active||18 and over||Pharmaceutical / Industry||BO25126|
TOC4939G, 2010-022902-41, BIG 04-11, NCT01358877
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus Herceptin (trastuzumab) as adjuvant therapy in patients with operable HER2-positive primary breast cancer. After surgery, patients will be randomized to receive either pertuzumab or placebo intravenously (iv) every 3 weeks for one year, in addition to 6-8 cycles of chemotherapy and 1 year of Herceptin (trastuzumab) iv every 3 weeks. Anticipated time on study treatment is 52 weeks. This study will be carried out in collaboration with the Breast International Group (BIG).
- Adult patients. >/= 18 years of age
- Non-metastatic primary invasive HER2-positive carcinoma of the breast that is adequately excised and that is node-positive (except T0)
- Eastern Cooperative Oncology Group (ECOG) performance status </=1
- The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first.
- Known hormone receptor status (estrogen receptor and progesterone receptor)
- Baseline LVEF >/= 55%
- Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the patient and/or partner for the duration of the study treatment and for at least 6 months after the last dose of study drug
- History of any prior (ipsi- and/or contralateral) invasive breast cancer
- History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
- Any "clinical" T4 tumor as defined by TNM, including inflammatory breast cancer
- Any previous systemic chemotherapy for cancer or radiotherapy for cancer
- Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
- Concurrent anti-cancer treatment in another investigational trial
- Serious cardiac or cardiovascular disease or condition
- Pregnant or lactating women
Trial Contact Information
Trial Lead Organizations/Sponsors
F. Hoffmann - La Roche, Limited
- Genentech Incorporated
- Breast International Group
Ph: 888-662-6728 (U.S. Only)
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01358877
ClinicalTrials.gov processed this data on May 21, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.