Fulvestrant With or Without Ganetespib in HR+ Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Metastatic, HR positive, ER positive
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed invasive breast cancer that is metastatic or unresectable locally advanced
- Estrogen and/or progesterone receptor positive breast cancer
- HER2 negative
- Measurable disease is required (effective 4/30/14: all non-measurable [evaluable] disease slots have been filled)
- Endocrine resistant breast cancer
- May have received up to one prior line of chemotherapy for metastatic or unresectable locally advanced breast cancer
- May have initiated bisphosphonate therapy prior to start of protocol therapy
- Must be at least 2 weeks from prior chemotherapy or radiotherapy
- ECOG performance status of 0 or 1
- Availability of tissue block from initial breast cancer diagnosis and/or metastatic recurrence
- For subjects with biopsy-accessible disease, must be willing to undergo a required on-treatment research biopsy
- Adequate IV access
Exclusion Criteria:
- Pregnant or breastfeeding
- Prior treatment with HSP90 inhibitor
- Prior treatment with fulvestrant
- Concurrent treatment with commercial agents or other agents with the intent to treat the participant's malignancy
- Untreated or progressive brain metastases
- Pending visceral crisis, in the opinion of the treating investigator
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to fulvestrant or ganetespib
- Uncontrolled intercurrent illness
- Other malignancies within 3 years
Sites / Locations
- DFCI at Faulkner Hospital
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
- New Hampshire Oncology and Hematology, P.A.
- University of North Carolina
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
ARM A - Fulvestrant
Arm B - Fulvestrant+Ganetespib
Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Eligible participants on Arm A were allowed to crossover to Arm B upon disease progression. Treatment continued for Arm A participants until 2nd disease progression.
Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Ganetespib: 200 mg/m2 administered intravenously on days 1, 8 and 15 of each 28 day cycle Arm B participants whose disease was at a minimum stable could elect to discontinue ganetespib after 6 cycles or stay on combination treatment until disease progression. Otherwise, Arm B participants taken off ganetespib for toxicity were to remain on single agent fulvestrant until disease progression.