Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer

Status: Recruiting
Phase: Phase 2
Diagnosis: Breast: Metastatic
NCT ID: NCT00470704 (View complete trial on
DFCI Protocol ID: 06-213


In this research study we are studying the effects of the combination of lapatinib plus Herceptin in subjects with breast cancer that has spread outside of the breast. We are also studying whether positron emission tomography (PET/CT) scans can predict which participants will benefit from the study treatment. Finally, we are studying genes and proteins in the tumor tissue that may lead to sensitivity or resistance to Herceptin, and to the combination of Herceptin plus lapatinib. Lapatinib is a compound that may stop cancer cells from growing. Other research studies suggest that lapatinib in combination with Herceptin may help to shrink or stabilize breast cancer.


Conducting Institutions:
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Brigham and Women's Hospital

Overall PI:
Nancy Lin, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Steven Come, MD, Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - Histologically or cytologically confirmed invasive breast cancer, with stage IV disease - HER2-positive breast cancer, defined as 3+ staining by IHC or gene amplification by FISH - Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension - Willingness to undergo a research biopsy of recurrent or metastatic disease - Prior chemotherapy treatment must be discontinued for at least 2 weeks prior to study entry. - Completed radiation therapy at least 7 days prior to beginning protocol treatment - Cohort 1: No prior chemotherapy for advanced breast cancer; no prior trastuzumab in the advanced breast cancer setting; nor prior treatment with lapatinib or other HER2-directed therapy other than trastuzumab - Cohort 2: Up to two prior chemotherapy regimens for the treatment of advanced breast cancer; no prior treatment with lapatinib or other HER2-directed therapy except for trastuzumab - 18 years of age or older - Life expectancy of greater than 12 weeks - ECOG Performance Status 0-2 - Normal organ and marrow function as outlined in protocol - Cardiac ejection fraction, as assessed by either MUGA scan or echocardiogram greater than or equal to 50% - Able to take oral medications Exclusion Criteria: - Patients may not be receiving any other investigational agents or concurrent chemotherapy or hormonal therapy for treatment of metastatic disease - Active brain metastases - History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or other agents used in this study - Clinically significant malabsorption syndrome - Uncontrolled intercurrent illness - Pregnant or breastfeeding women - Concurrent use of the medications listed in the protocol because of possible interaction with lapatinib
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