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Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer

Status: Recruiting
Phase: Phase 2
Diagnosis: Breast: Metastatic
NCT ID: NCT01441947 (View complete trial on
DFCI Protocol ID: 11-208


The study drug cabozantinib works by inhibiting several different proteins which are believed to be involved in breast cancer tumor growth, its ability to spread, and its ability to form new blood vessels. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to prevent cancer growth. The single agent portion of this study is now closed to accrual. This research study is now examining the efficacy of cabozantinib in combination with fulvestrant for treatment of hormone-receptor-positive breast cancer that has spread to bone.


Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center

Overall PI:
Steven Isakoff, MD, PhD, Massachusetts General Hospital

Site-responsible Investigators:
Sara Tolaney, MD, Dana-Farber Cancer Institute
Steven Come, MD, Beth Israel Deaconess Medical Center

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
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: - Clear evidence of metastases to bone on isotope bone scan - Histologically or cytologically confirmed metastatic Estrogen-receptor-positive (ER+) and/or Progesterone-receptor-positive (PR+) and HER2 negative breast cancer - Received at least one prior line of hormonal or chemo-therapy for metastatic disease - must be post menopausal - Recovered from toxicities related to prior treatment, except alopecia, lymphopenia, or other non-clinically significant Adverse Events (AEs) - Life expectancy > 3 months - Adequate organ and marrow function - Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception - Able to lie flat for up to 45 minutes for imaging studies - Able to swallow capsules or tablets Exclusion Criteria: - Pregnant or breast-feeding - Has experienced clinically-significant hematemesis or hemoptysis of > 0.5 teaspoons of red blood, or other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment - Untreated, symptomatic or uncontrolled brain metastasis requiring current treatment including steroids and anti-convulsants - more than 1 prior line of chemotherapy for treatment of metastatic breast cancer - prior treatment with fulvestrant - Requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or coumadin-related agents, thrombin or FXa inhibitors, and antiplatelet agents (eg, clopidogrel) - Uncontrolled or significant intercurrent illness - Gastrointestinal disorders, particularly those associated with a high risk of perforation or fistula formation - Active infection requiring systemic treatment - Serious non-healing wound/ulcer/bone fracture - History of organ transplant - Concurrent uncompensated hypothyroidism or thyroid dysfunction - Previously-identified allergy or hypersensitivity to components of the study treatment formulation - Diagnosis of another malignancy, requiring systemic treatment, within the last 2 years, unless non-melanoma skin cancer, in-situ carcinoma of the cervix, or superficial bladder cancer
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