A Phase II Trial of Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer With Involvement of Bone
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Bone Scan Response Rate
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.
2 years
No
Michaela J Higgins, MD, MRCPI
Principal Investigator
Massachusetts General Hospital
United States: Food and Drug Administration
11-208
NCT01441947
October 2011
December 2013
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |