Cabozantinib for Metastatic Triple Negative BrCa

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

In this research study, we are looking at the anti-tumor effects of Cabozantinib (XL184) in metastatic breast cancer. Data suggest that MET expression and activation are important for initiation and progression of triple-negative breast cancer (TNBC). We evaluated the efficacy of cabozantinib (XL184), a novel inhibitor of multiple receptor tyrosine kinases, including MET and VEGFR2, in patients with metastatic TNBC.

Key facts

Study ID

NCT01738438

Run by

Dana-Farber Cancer Institute

People needed

35

Starts

2013-02-01

Expected to finish

2015-05-01

Last updated by the study team

2016-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana-Farber Cancer Institute at Faulkner Hospital — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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