Breast Cancer Clinical Trial
Cabozantinib for Metastatic Triple Negative BrCa
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.
Full Description
OBJECTIVES:
Primary
* To evaluate the activity of cabozantinib, as defined by objective response rate in patients with triple-negative metastatic breast cancer
Secondary
To evaluate progression free survival
To evaluate c-Met and phospho c-Met expression in archival tumor tissue
To evaluate the incidence of c-Met amplified circulating tumor cells at baseline
To evaluate potential plasma biomarkers of cabozantinib
DESIGN:
This study uses a two-stage design enrolling 35 patients to evaluate efficacy of cabozantinib based on overall response defined as complete or partial response per RECIST1.1 criteria. The null and alternative overall response rates were 5% and 20%. If one or more patients enrolled in the stage one cohort (n=13 patients) achieve PR or better then accrual proceeds to stage two (n=22 patients).
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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There are 3 Locations for this study
Boston Massachusetts, 02130, United States
Boston Massachusetts, 02214, United States
Boston Massachusetts, 02215, United States
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