Randomized Phase II Study of Fulvestrant With or Without Ganetespib in Patients With Hormone Receptor-Positive, Metastatic Breast Cancer
18 Years
N/A
Both
Breast Cancer
Trial Information
Randomized Phase II Study of Fulvestrant With or Without Ganetespib in Patients With Hormone Receptor-Positive, Metastatic Breast Cancer
Because no one knows which of the study options is best, you will be "randomized" into one
of the study groups: Arm A: Fulvestrant or Arm B: Fulvestrant plus Ganetespib. You will have
a one-third chance of being placed in Arm A and a two-thirds chance of being placed in Arm
B.
If you are initially placed in Arm A but your disease progresses, you will have the option
of receiving the combination of fulvestrant plus ganetespib as part of Arm C.
You will undergo the following procedures during the research study: study drug(s), blood
tests, clinical exams and scans/imaging tests.
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 or evaluable disease is allowed
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Effect of Adding Ganetespib to Fulvestrant
Outcome Description:
Evaluate the effect of the addition of ganetespib to fulvestrant on progression-free survival (PFS), compared to fulvestrant alone
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Nancy U Lin, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
11-477
NCT ID:
NCT01560416
Start Date:
May 2012
Completion Date:
Related Keywords:
- Breast Cancer
- Metastatic
- HR positive
- ER positive
- Breast Neoplasms
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
| DFCI at Faulkner Hospital | Boston, Massachusetts 02130 |
