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New pill shows promise against tough breast cancer

NCT ID NCT04505826

Disease control Sponsor: Olema Pharmaceuticals, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a new oral drug called OP-1250 in 153 adults with advanced or metastatic hormone-receptor-positive, HER2-negative breast cancer. The drug works by blocking estrogen receptors more completely than current therapies. The trial aimed to find the best dose, check safety, and see if the drug can shrink tumors.

What this could mean

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

Active substance
OP-1250 (a new oral drug that blocks estrogen receptors)
What this could lead to
If successful, this could provide a new treatment option for people with advanced hormone-receptor-positive breast cancer that has stopped responding to current hormone therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 153 participants, so results may not apply to all patients. The drug may cause side effects or fail to shrink tumors in many cases.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

153 people

The number who actually took part.

Started

Aug 2020

Finished

Jul 2024

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: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease * Must not have received prior oral endocrine therapy \< 2 weeks prior to first dose * Must not have received prior, chemotherapy in 2 weeks or within 5 half-lives whichever is earlier, antibody therapy within 4 weeks or investigational therapy within 4 weeks or 5 half-lives whichever is earlier, prior to the first dose * Adequate hepatic function * Adequate renal function * Normal coagulation panel * Willingness to use effective contraception Key Exclusion Criteria: * Gastrointestinal disease * Significant renal disease * Significant cardiovascular disease * Significant ECG abnormalities * Ongoing systemic bacterial, fungal, or viral infection (requiring antimicrobial therapy) * Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

Her2-receptor negative breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

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

HER2-negative breast cancer Hormone receptor-positive breast carcinoma

Contacts and locations

Locations

  • Advent Health

    Orlando, Florida, 32804, United States

  • Cancer Research South Australia

    Adelaide, South Australia, 5000, Australia

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Center

    Sarasota, Florida, 34232, United States

  • ICON Cancer Centre

    Auchenflower, Queensland, 4066, Australia

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Macquarie University

    Sydney, New South Wales, 2109, Australia

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • UCLA Hematology/Oncology

    Los Angeles, California, 90404, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Miami, Sylvester Comprehensive Cancer Center

    Deerfield Beach, Florida, 33442, United States

  • Westmead

    Westmead, New South Wales, 2145, Australia

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.