Cabozantinib for Metastatic Triple Negative BrCa

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute

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