Fulvestrant With or Without Ganetespib in HR+ Breast Cancer

NCT ID: NCT01560416

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARM A - Fulvestrant

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.

Group Type: ACTIVE_COMPARATOR

Fulvestrant

Intervention Type: DRUG

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 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 Type: ACTIVE_COMPARATOR

Fulvestrant

Intervention Type: DRUG

Ganetespib

Intervention Type: DRUG

Interventions

Fulvestrant

Intervention Type: DRUG

Ganetespib

Intervention Type: DRUG

Other Intervention Names

Faslodex; STA9090

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Nancy Lin, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy U Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

DFCI at Faulkner Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

New Hampshire Oncology and Hematology, P.A.

Concord, New Hampshire, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

11-477

Identifier Type: -

Identifier Source: org_study_id