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Can a prostate cancer drug boost breast cancer treatment?

NCT ID NCT02955394

Disease control Sponsor: University of Colorado, Denver 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether adding enzalutamide, a drug used for prostate cancer, to the standard hormone therapy fulvestrant helps women with a certain type of breast cancer. The study includes postmenopausal women with ER+/Her2- breast cancer who will receive the treatment for about four months before surgery. The main goal is to see if the combination lowers the risk of cancer coming back after surgery, measured by a score called PEPI.

What this could mean

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

Active substance
Fulvestrant with or without enzalutamide
What this could lead to
If adding enzalutamide to fulvestrant lowers the risk of cancer recurrence after surgery, it could offer a new treatment option for this type of breast cancer.
What could go wrong
This is a phase II trial with only 61 participants, so results may not apply broadly. Adding enzalutamide may not improve outcomes and could cause additional side effects.

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

61 people

The number who actually took part.

Started

Sep 2017

Expected to finish

Feb 2027

An estimate. End dates often move.

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 to 101 years

Sex

Female participants only

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: * ER+ Her2- breast cancer * Stage at least T2 or greater * Planned to get local surgery * Postmenopausal, or if pre- or peri- menopausal, then will need to have concurrent ovarian suppression. * At least 18 years of age * Not on anticoagulants * PS 0-2 * Able to swallow study drug and comply with study requirements * ANC \>1000/uL, platelets \>75,000/uL at screening visit * Total bilirubin \< 1.5 times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (eg, Gilbert's disease) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 3 times ULN or \< 5 times ULN if patient has documented liver metastases * Creatinine \< 1.5 times ULN * INR \< 1.5 times ULN, or if on warfarin, can safely transition off for biopsy * Willing to donate blood for research at 4 time points * Willing to undergo core biopsies for research at study entry and at \~4 weeks. * Willing to donate tissue to research from the surgical specimen * Written informed consent obtained prior to biopsies and blood samples Exclusion Criteria: * Current or previously treated brain or leptomeningeal metastases * History of seizures * Prior treatment with an anti-androgen (abiraterone, ARN-509, bicalutamide, enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700, VT-464). * Systemic estrogens or androgens within 14 days before initiating therapy. Vaginal estrogens are allowed if necessary for patient comfort.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • West Cancer Center

    Germantown, Tennessee, 38138, United States

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