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:||Intervention Model: Single Group Assignment
Masking: No masking
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 ]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 ]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 ]To evaluate Overall Survival
- Progression Free Survival [ Time Frame: 2 years ]To evaluate Progression Free Survival
- Effects on bone and tumor markers [ Time Frame: 2 years ]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 ]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.
- Fluorodeoxyglucose Positron Emission Tomography(FDG-PET) Response Rate [ Time Frame: 2 years ]To evaluate FDG-PET response rate
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Experimental: Cabozantinib plus fulvestrant
Combination therapy with cabozantinib 60 mg daily plus fulvestrant 500 mg monthly Intramuscularly (IM)
Part of combination arm
Other Name: XL184Drug: Fulvestrant
part of combination arm
Other Name: Faslodex
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441947
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02214|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Steven J Isakoff, MD, PhD||Massachusetts General Hospital|