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Can a new pill outsmart resistant breast cancer?

NCT ID NCT07766018

Disease control Sponsor: Stemline Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This trial is testing an oral drug called elacestrant in Japanese patients with a specific type of advanced breast cancer (ER+/HER2-) that has a mutation in the ESR1 gene and has progressed after prior endocrine therapy including a CDK4/6 inhibitor. The study aims to see if elacestrant can slow down the cancer's growth and to assess its safety. Participants will take elacestrant as a tablet, and the trial will monitor their response and any side effects.

What this could mean

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

Active substance
elacestrant (an oral drug taken as a tablet)
What this could lead to
If successful, this could provide a new treatment option for Japanese patients with a specific type of advanced breast cancer that has stopped responding to prior therapies.
What could go wrong
This is a phase 2 trial with a small number of participants, so results may not be conclusive. The drug may not be effective or could cause 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

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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.

Key Inclusion Criteria: * Must have a histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy * Female participants must be post-menopausal (as defined by the protocol) * Must have ER+ and HER2- tumor status confirmed per local laboratory testing * Participants must be ESR1-mutant positive determined via testing with the Guardant360 Companion Diagnostic panel test prior to enrollment * Must have disease progression during or within 28 days of completion of prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (this counts as a line of prior endocrine therapy) for metastatic breast cancer Key Exclusion Criteria: * Prior treatment with: elacestrant or investigational or approved selective estrogen receptor degrader or ER antagonist; antibody-drug conjugate therapy for advanced/metastatic breast cancer; anti-cancer or investigational drug treatment * Radiation therapy within 14 days (28 days for brain lesions) before the first dose of study drug * Intact uterus with a history of endometrial intraepithelial neoplasia (atypical endometrial hyperplasia or higher-grade lesion) * Diagnosis of any other malignancy within 5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or second primary breast cancer Note: Other protocol-defined inclusion/exclusion criteria may apply.

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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 ER+/HER2- advanced or metastatic breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chiba Cancer Center

    RECRUITING

    Chiba, Japan

  • Juntendo University Hospital

    RECRUITING

    Tokyo, Japan

  • Kumamoto Shinto General Hospital

    RECRUITING

    Kumamoto, Japan

  • Kumamoto University Hospital

    RECRUITING

    Kumamoto, Japan

  • Kyushu University Hospital

    RECRUITING

    Fukuoka, Japan

  • National Hospital Organization - Hokkaido Cancer Center

    RECRUITING

    Sapporo, Japan

  • National Hospital Organization - Kyushu Medical Center

    RECRUITING

    Fukuoka, Japan

  • National Hospital Organization - Osaka National Hospital

    RECRUITING

    Osaka, Japan

  • Saitama Cancer Center

    RECRUITING

    Ina, Japan

  • The Cancer Institute Hospital of JFCR (Japanese Foundation For Cancer Research)

    RECRUITING

    Kōtō City, Japan

  • Tokai University Hospital

    RECRUITING

    Isehara, Japan

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