NCT01560416

Randomized Phase II Study of Fulvestrant With or Without Ganetespib in Patients With Hormone Receptor-Positive, Metastatic Breast Cancer

Completed Phase 2 Results posted Last updated 18 February 2026

What this trial tests

Phase 2 trial testing Fulvestrant in Breast Cancer in 50 participants. Completed in 26 June 2016.

Timeline

1 June 2012

Primary endpoint
26 June 2016

26 June 2016

Quick facts

Lead sponsor	Dana-Farber Cancer Institute
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 June 2012
Primary completion	26 June 2016
Estimated completion	26 June 2016
Sites	5 locations across United States

Drugs / interventions tested

• Fulvestrant (fulvestrant) — full drug profile →
• Ganetespib — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Dana-Farber Cancer Institute

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Progression-Free Survival (PFS)
  Time frame: 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.
  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.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Investigational chemotherapy and novel pharmacokinetic mechanisms for the treatment of breast cancer brain metastases.
   Shah N, Mohammad AS, Saralkar P, Sprowls SA, et al · · 2018 · cited 102× · PMID 29604436 · DOI 10.1016/j.phrs.2018.03.021
2. Ganetespib: research and clinical development.
   Jhaveri K, Modi S. · · 2015 · cited 70× · PMID 26244021 · DOI 10.2147/ott.s65804
3. Targeting Heat-Shock Protein 90 in Cancer: An Update on Combination Therapy.
   Ren X, Li T, Zhang W, Yang X. · · 2022 · cited 36× · PMID 36010632 · DOI 10.3390/cells11162556
4. Mechanisms behind context-dependent role of glucocorticoids in breast cancer progression.
   Butz H, Patócs A. · · 2022 · cited 17× · PMID 35761157 · DOI 10.1007/s10555-022-10047-1
5. Biomarkers That Predict Sensitivity to Heat Shock Protein 90 Inhibitors.
   Jhaveri K, Chandarlapaty S, Iyengar N, Morris PG, et al · · 2016 · cited 13× · PMID 26726007 · DOI 10.1016/j.clbc.2015.11.004
6. Hypoxia-Inducible Factor-Dependent and Independent Mechanisms Underlying Chemoresistance of Hypoxic Cancer Cells.
   Lee PWT, Koseki LR, Haitani T, Harada H, et al · · 2024 · cited 12× · PMID 38730681 · DOI 10.3390/cancers16091729
7. Amino acid metabolism in breast cancer: pathogenic drivers and therapeutic opportunities.
   Liu Y, Zong X, Altea-Manzano P, Fu J. · · 2025 · cited 8× · PMID 39973065 · DOI 10.1093/procel/pwaf011
8. Hsp90 inhibitors in oncology: ready for prime time?
   Parimi S, Tsang RY. · · 2014 · cited 5× · PMID 25301415 · DOI 10.3747/co.21.2163