← Back to Search

Hormone Therapy

Fulvestrant +/− Ganetespib for Breast Cancer

Phase 2
Waitlist Available
Led By Nancy U Lin, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HER2 negative
Endocrine resistant breast cancer
Must not have
Uncontrolled intercurrent illness
Prior treatment with HSP90 inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up disease was assessed radiographically every 2 cycles for year 1 and every 2-4 cycles longer-term. participants in this study cohort were followed for survival up to 4 years from treatment end.
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trial is testing a drug combo (ganetespib+fulvestrant) to see if it can improve the effectiveness of treatment for metastatic hormone-receptor positive breast cancer.

Who is the study for?
This trial is for individuals with hormone receptor-positive, metastatic breast cancer that's HER2 negative. Participants can have had one prior chemotherapy treatment and must have measurable disease. They should be in good physical condition (ECOG status of 0 or 1) and not currently pregnant or breastfeeding. Those who've previously used fulvestrant or HSP90 inhibitors, have untreated brain metastases, other recent cancers, or severe illnesses are excluded.
What is being tested?
The study is testing the effectiveness of combining Ganetespib, an HSP90 inhibitor thought to prevent cancer cell resistance, with Fulvestrant, a hormonal therapy approved by the FDA for certain breast cancers. The goal is to see if adding Ganetespib improves outcomes compared to using Fulvestrant alone.
What are the potential side effects?
Potential side effects include reactions related to immune system suppression such as increased infection risk; organ inflammation; fatigue; digestive issues like nausea and diarrhea; blood disorders; and allergic reactions specific to either drug's components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is not HER2 positive.
Select...
My breast cancer has not responded to hormone therapy.
Select...
My breast cancer has spread and cannot be removed by surgery.
Select...
My breast cancer is positive for estrogen or progesterone.
Select...
I have a tissue sample from my initial or recurrent breast cancer.
Select...
I am fully active or can carry out light work.
Select...
I am willing to have a biopsy if my disease can be easily accessed for it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any unmanaged ongoing illnesses.
Select...
I have been treated with an HSP90 inhibitor before.
Select...
I have been treated with fulvestrant before.
Select...
I am not currently receiving any other cancer treatments.
Select...
I have brain metastases that are either untreated or getting worse.
Select...
I have not had any other cancers in the last 3 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~disease was assessed radiographically every 2 cycles for year 1 and every 2-4 cycles longer-term. participants in this study cohort were followed for survival up to 4 years from treatment end.
This trial's timeline: 3 weeks for screening, Varies for treatment, and disease was assessed radiographically every 2 cycles for year 1 and every 2-4 cycles longer-term. participants in this study cohort were followed for survival up to 4 years from treatment end. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-Free Survival (PFS)
Secondary study objectives
Clinical Benefit Rate (CBR)
Grade 3-4 Toxicity Rate
Objective Response Rate (ORR)
+1 more

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Arm B - Fulvestrant+GanetespibActive Control2 Interventions
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.
Group II: ARM A - FulvestrantActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,103 Previous Clinical Trials
359,325 Total Patients Enrolled
144 Trials studying Breast Cancer
21,769 Patients Enrolled for Breast Cancer
Nancy U Lin, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
6 Total Patients Enrolled
1 Trials studying Breast Cancer
6 Patients Enrolled for Breast Cancer
~4 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top