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New drug combo shows promise in resistant breast cancer

NCT ID NCT01560416

Disease control Sponsor: Dana-Farber Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tested whether adding ganetespib, an experimental drug that blocks a protein called HSP90, to the standard hormone therapy fulvestrant could help people with hormone receptor-positive metastatic breast cancer that has stopped responding to hormone treatment. The study enrolled 50 participants and measured how long the cancer stayed under control (progression-free survival) and side effects. The goal was to see if the combination works better than fulvestrant alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fulvestrant (Faslodex) and ganetespib (STA9090)
What this could lead to
If adding ganetespib to fulvestrant works, it could offer a new treatment option for people with hormone receptor-positive metastatic breast cancer that has become resistant to hormone therapy.
What could go wrong
This is a small, early-phase (phase 2) study with only 50 participants, so results may not apply to everyone. The combination may cause more side effects (like grade 3-4 toxicity) without improving outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

50 people

The number who actually took part.

Started

Jun 2012

Finished

Jun 2016

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215, United States

  • DFCI at Faulkner Hospital

    Boston, Massachusetts, 02130, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • New Hampshire Oncology and Hematology, P.A.

    Concord, New Hampshire, 03301, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

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