Fulvestrant With or Without Ganetespib in HR+ Breast Cancer

NCT01560416 | Completed Phase 2 Results DMC

• 1 other identifier: 11-477
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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.

Conditions

Breast Cancer

Keywords

Metastatic; HR positive; ER positive

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS based on Kaplan-Meier is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD are censored at the date of last disease assessment. Participants who receive non-protocol anti-cancer therapy before disease progression are censored at time of last disease assessment.

  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.

Secondary Outcomes (4)

• Grade 3-4 Toxicity Rate

  AEs were assessed every cycle on treatment (weeks 2-3 on cycle 1). Median treatment duration was 4 cycles/~4 months on each arm. Maximum treatment duration was 41 cycles (Arm A) and 42 cycles (Arm B) which approximates 38 months.

• Objective Response Rate (ORR)

  Disease was assessed radiographically every 2 cycles for year 1 and every 2-4 cycles thereafter on treatment. Maximum treatment duration was 41 cycles (Arm A) and 42 cycles (Arm B) which approximates 38 months.

• Clinical Benefit Rate (CBR)

  Disease was assessed radiographically every 2 cycles for year 1 and every 2-4 cycles thereafter on treatment. Maximum treatment duration was 41 cycles (Arm A) and 42 cycles (Arm B) which approximates 38 months.

• Overall Survival (OS)

  Participants were followed long-term for survival every 3 months from the end of treatment until death, lost to follow-up or up to 4 years from treatment end. Median survival follow-up was 28 months for the study cohort.

Study Arms (2)

ARM A - Fulvestrant

ACTIVE COMPARATOR

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.

Drug: Fulvestrant

Arm B - Fulvestrant+Ganetespib

ACTIVE COMPARATOR

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.

Drug: Fulvestrant; Drug: Ganetespib

Interventions

Fulvestrant DRUG

Also known as: Faslodex

ARM A - Fulvestrant; Arm B - Fulvestrant+Ganetespib

Ganetespib DRUG

Also known as: STA9090

Arm B - Fulvestrant+Ganetespib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (5)

DFCI at Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

New Hampshire Oncology and Hematology, P.A.

Concord, New Hampshire, 03301, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Fulvestrant; STA 9090

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Nancy Lin
• Organization: Dana-Farber Cancer Institute

Nancy_Lin@dfci.harvard.edu

617-632-2335

Study Officials

• Nancy U Lin, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomized 2:1 B Fulvestrant+Ganetespib:A Fulvestrant

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 22, 2012
• Study Start: June 1, 2012
• Primary Completion: June 26, 2016
• Study Completion: June 26, 2016
• Last Updated: March 3, 2026
• Results First Posted: January 3, 2019

Record last verified: 2026-02

Locations

US (5)