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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

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My cancer is not HER2 positive.

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My breast cancer has not responded to hormone therapy.

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My breast cancer has spread and cannot be removed by surgery.

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My breast cancer is positive for estrogen or progesterone.

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I have a tissue sample from my initial or recurrent breast cancer.

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I am fully active or can carry out light work.

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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:

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I do not have any unmanaged ongoing illnesses.

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I have been treated with an HSP90 inhibitor before.

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I have been treated with fulvestrant before.

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I am not currently receiving any other cancer treatments.

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I have brain metastases that are either untreated or getting worse.

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I have not had any other cancers in the last 3 years.

Timeline

Screening ~ 3 weeks3 visits

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.

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.

0 / 13Eligibility criteria met