Cabozantinib for Metastatic Triple Negative BrCa

Status: Recruiting
Phase: Phase 2
Diagnosis: Breast: Metastatic
NCT ID: NCT01738438 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-431

 

This research study is Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is being studied. It also means that the FDA has not yet approved XL184 for use in patients, including people with your type of cancer. XL184 is a drug that may stop cancer cells from growing. It is a small molecule kinase inhibitor that inhibitors met and VEGFR2, as well as other targets. This drug has been used in Phase I studies in humans and laboratory experiments, and information from those other research studies suggests that this drug may help to slow tumor progression in this research study. This drug has also been used in a phase II study for breast cancer patients (a randomized discontinuation trial) suggesting good benefit for this group of patients. In this research study, we are looking at the anti-tumor effects of XL184 in metastatic breast cancer.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Dana Farber Cancer Institute at Faulkner Hospital, Massachusetts General Hospital

Overall PI:
Erica Mayer, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Sara Tolaney, MD, Dana-Farber Cancer Institute
Michaela Higgins, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Histologically or cytologically confirmed invasive breast cancer with stage IV disease - Primary tumor and/or metastasis must be ER-negative, PR-negative and HER2-negative - May have received 0-3 prior chemotherapeutic regimens for metastatic breast cancer. Must be off treatment for at least 21 days prior to enrollment - Must have discontinued all biologic therapy at least 14 days before enrollment - May have received prior radiation therapy in the early stage or metastatic setting, but must have completed treatment at least 14 days prior to enrollment - Must agree to use medically acceptable methods of contraception - Confirmed availability of formalin-fixed, paraffin-embedded tumor tissue - Able to swallow tablets Exclusion Criteria: - Pregnant or breastfeeding - Received another investigational agent within 14 days prior to enrollment - Received prior c-Met inhibitor - Known brain metastases that are untreated, symptomatic or require therapy to control symptoms - Psychiatric illness or social situation that could limit ability to comply with study requirements - Require concomitant treatment in therapeutic doses with anticoagulants or antiplatelet agents - Diagnosis of another malignancy requiring systemic treatment within the last two years (except non-melanoma skin cancer or in-situ carcinoma of the cervix) - Known to be positive for HIV - Active infection requiring IV antibiotics at Day 1 of cycle 1 - Uncontrolled, significant intercurrent illness - Requires chronic concomitant treatment of a strong CYP3A4 inducer - tumor in contact with, invading or encasing major blood vessels - Have experienced clinically significant gastrointestinal bleeding within 6 months, hemoptysis of more than 0.5 teaspoon of red blood within 3 months or other signs indicative of pulmonary hemorrhage within 3 months of enrollment
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