Breast Cancer Clinical Trial
Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer
Summary
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.
Full Description
Cabozantinib will be taken orally once a day in cycles of 28 days (4 weeks). Fulvestrant will be given intramuscularly on days 1 and 15 of cycle 1 and on day 1 of all subsequent cycles.
On Day 1 of each cycle subjects will have the following tests and procedures:
Performance status
Physical exam
Vital signs
Routine blood samples
Blood and urine samples to look at bone markers (Cycle 1 through 6 only)
Subjects will also have the following additional tests and procedures:
Tumor assessment by Computed Tomography (CT) scan and bone scan at Cycle 3, then every 12 weeks
Blood or urine pregnancy test (if applicable) on Day 1 of Cycles 1, 2, 4, then every 12 weeks
Urine sample and blood test for thyroid function (Cycle 1, 3, 5, then every 6 weeks)
Blood test for breast cancer tumor marker (Cycle 1 and 4, then every 6 weeks)
Pain questionnaire and painkiller medication diary at 7-day intervals during Week 3, Week 6, and every 6 weeks thereafter.
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 Human Epidermal Growth Factor Receptor (HER) 2 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 Factor Xa 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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There are 3 Locations for this study
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02214, United States
New York New York, 10065, United States
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