Status:
COMPLETED
Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Exelixis
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ves...
Detailed 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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2019
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01441947
Start Date
October 1 2011
End Date
August 9 2019
Last Update
May 25 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065