Fulvestrant +/− Ganetespib for Breast Cancer

Recruiting at4 trial locations

Overseen by Nancy U Lin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Ganetespib is a drug that may stop cancer cells from growing. This drug has been used in other research studies and laboratory experiments. It has also been studied in phase I trials, where the appropriate dosing has been determined. Ganetespib is considered an "HSP90 inhibitor". By blocking HSP90, ganetespib is thought to reduce the ability of cancer cells to become resistant to treatment. Fulvestrant is a hormonal therapy that works by attaching to estrogen receptors. In doing so, it can block the effect of estrogen on cancer cells. In addition, fulvestrant causes a decrease in the number of estrogen receptors. Fulvestrant is a drug that is approved by the FDA for treatment of metastatic, hormone receptor positive breast cancer, based upon the results of phase III clinical trials. In the laboratory, adding ganetespib to fulvestrant appears to improve its effectiveness. It is not known whether this is true in humans. In this research study, we are evaluating the effect of the addition of ganetespib to fulvestrant in participants with hormone receptor-positive, metastatic breast cancer.

Research Team

Nancy U Lin, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

My cancer is not HER2 positive.

You need to have a way to measure the disease for the study.

My breast cancer has not responded to hormone therapy.

Exclusion Criteria

Pregnant or breastfeeding

You are at risk of a severe medical issue, according to the doctor in charge of your treatment.

You have had allergic reactions to drugs similar to fulvestrant or ganetespib.

Treatment Details

Interventions

• Fulvestrant (Hormone Therapy)
• Ganetespib (HSP90 Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Arm B - Fulvestrant+Ganetespib Active Control 2 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 - Fulvestrant Active Control 1 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.

Fulvestrant is already approved in Canada, Japan for the following indications:

Approved in Canada as Faslodex for:

• Hormone receptor-positive metastatic breast cancer
• Locally advanced breast cancer

Approved in Japan as Faslodex for:

• Hormone receptor-positive metastatic breast cancer
• Locally advanced breast cancer

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management