Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer With Involvement of Bone|
- Bone Scan Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate the bone scan response rate in patients with hormone-receptor-positive breast cancer with bone metastases receiving cabozantinib. Bone scan response rate will be defined as the percentage of patients experiencing a complete resolution or significant improvement in the bone scan.
- Overall Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate overall response rate (ORR) (defined as the percentage of patients experiencing a complete response or partial response)
- Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate Overall Survival
- Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate Progression Free Survival
- Effects on bone and tumor markers [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate the effects of cabozantinib on biochemical markers of bone turnover and tumor markers
- Skeletal related event rates (includes analgesic usage, incidence of fractures, need for radiation or surgical intervention and pain at sites of bone disease) [ Time Frame: 2 years ] [ Designated as safety issue: No ]All intercurrent adverse events, treatments and interventions will be recorded. For the purpose of determining the effects of cabozantinib treatment on pain and analgesic medication usage, pain will be assessed by a participant-reported questionnaire, and daily analgesic medication usage will be recorded during regular intervals.
- FDG-PET (Flurodeoxyglucose Positron Emission Tomography) Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate FDG-PET response rate
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Drug: Cabozantinib and fulvestrant
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441947
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02214|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Michaela J Higgins, MD, MRCPI||Massachusetts General Hospital|