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New hope for advanced breast cancer: phase 3 trial launches

NCT ID NCT07085767

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This phase 3 trial is testing a new drug called palazestrant (OP-1250) combined with ribociclib against the standard letrozole plus ribociclib for people with ER+, HER2- advanced breast cancer who haven't had prior treatment. About 1,000 participants will be randomly assigned to one of the two combinations. The main goal is to see if the new combo slows cancer growth better than the current approach.

What this could mean

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

Active substance
palazestrant (OP-1250) and ribociclib
What this could lead to
If successful, this could offer a new first-line treatment option for people with ER+, HER2- advanced breast cancer, potentially delaying disease progression.
What could go wrong
This is a large phase 3 trial, but the experimental drug is still being tested. It may not prove better than the current standard, and side effects like low blood cell counts or liver issues are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,000 people

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

Started

Nov 2025

Expected to finish

Jan 2032

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.

Inclusion Criteria: * Adult female or male participants. * ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy. * Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease). * De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematologic, hepatic, and renal functions. * Female participants can be pre-, peri- or postmenopausal. * Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist. Exclusion Criteria: * Disease recurrence during adjuvant endocrine therapy * Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer. * Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting. * History of allergic reactions to study treatment. * Any contraindications to letrozole and ribociclib. * Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm estrogen-receptor positive breast cancer 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.

Breast cancer ER positive breast cancer HER2-negative breast carcinoma Locally advanced breast cancer 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

    135 sites in 22 countries. 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

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Hot Springs, Arkansas, 71913, United States

  • Clinical Trial Site

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Clinical Trial Site

    RECRUITING

    La Jolla, California, 92093, United States

  • Clinical Trial Site

    RECRUITING

    Los Alamitos, California, 90720, United States

  • Clinical Trial Site

    RECRUITING

    San Francisco, California, 94115, United States

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Santa Barbara, California, 93105, United States

  • Clinical Trial Site

    RECRUITING

    Vallejo, California, 94589, United States

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Aurora, Colorado, 80045, United States

  • Clinical Trial Site

    RECRUITING

    Denver, Colorado, 80220, United States

  • Clinical Trial Site

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    New Haven, Connecticut, 06511, United States

  • Clinical Trial Site

    RECRUITING

    Tampa, Florida, 33612, United States

  • Clinical Trial Site

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    Marietta, Georgia, 30060, United States

  • Clinical Trial Site

    RECRUITING

    Honolulu, Hawaii, 96813, United States

  • Clinical Trial Site

    RECRUITING

    Peoria, Illinois, 61615, United States

  • Clinical Trial Site

    RECRUITING

    Urbana, Illinois, 61801, United States

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Ames, Iowa, 50010, United States

  • Clinical Trial Site

    RECRUITING

    Scarborough, Maine, 04074, United States

  • Clinical Trial Site

    RECRUITING

    Annapolis, Maryland, 21401, United States

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Catonsville, Maryland, 21228, United States

  • Clinical Trial Site

    RECRUITING

    Burlington, Massachusetts, 01805, United States

  • Clinical Trial Site

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Jackson, Mississippi, 39216, United States

  • Clinical Trial Site

    RECRUITING

    Kansas City, Missouri, 64132, United States

  • Clinical Trial Site

    RECRUITING

    Santa Fe, New Mexico, 87505, United States

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    New York, New York, 10032, United States

  • Clinical Trial Site

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Clinical Trial Site

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • Clinical Trial Site

    RECRUITING

    Columbus, Ohio, 43219, United States

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Portland, Oregon, 97239, United States

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Horsham, Pennsylvania, 19044, United States

  • Clinical Trial Site

    RECRUITING

    Sayre, Pennsylvania, 18840, United States

  • Clinical Trial Site

    RECRUITING

    Bartlett, Tennessee, 38133, United States

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Knoxville, Tennessee, 37909, United States

  • Clinical Trial Site

    RECRUITING

    Mount Juliet, Tennessee, 37122, United States

  • Clinical Trial Site

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Clinical Trial Site

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    Tennessee City, Tennessee, 37203, United States

  • Clinical Trial Site

    RECRUITING

    Denton, Texas, 76201, United States

  • Clinical Trial Site

    RECRUITING

    El Paso, Texas, 79902, United States

  • Clinical Trial Site

    RECRUITING

    Houston, Texas, 77024, United States

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    San Antonio, Texas, 78229, United States

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Salt Lake City, Utah, 84106, United States

  • Clinical Trial Site

    RECRUITING

    Fort Belvoir, Virginia, 22060, United States

  • Clinical Trial Site

    RECRUITING

    Midlothian, Virginia, 23114, United States

  • Clinical Trial Site

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • Clinical Trial Site

    RECRUITING

    Olympia, Washington, 98502, United States

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Vancouver, Washington, 98684, United States

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Milwaukee, Wisconsin, 52336, United States

  • Clinical Trial Site

    RECRUITING

    Sydney, New South Wales, 2109, Australia

  • Clinical Trial Site

    RECRUITING

    Waratah, New South Wales, 2298, Australia

  • Clinical Trial Site

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Clinical Trial Site

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Clinical Trial Site

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Clinical Trial Site

    RECRUITING

    Geelong, Victoria, 3220, Australia

  • Clinical Trial Site

    RECRUITING

    Heidelberg, Victoria, 03084, Australia

  • Clinical Trial Site

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Krems, Lower Austria, 3500, Austria

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Salzburg, State of Salzburg, 5020, Austria

  • Clinical Trial Site

    RECRUITING

    Linz, Upper Austria, 4010, Austria

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Wels, Upper Austria, 4600, Austria

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Brussels, Brussels Capital, 1090, Belgium

  • Clinical Trial Site

    RECRUITING

    Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

  • Clinical Trial Site

    RECRUITING

    Kortrijk, Flanders, 8500, Belgium

  • Clinical Trial Site

    RECRUITING

    Liège, Liège Province, 4000, Belgium

  • Clinical Trial Site

    RECRUITING

    Charleroi, Wallonia, 6060, Belgium

  • Clinical Trial Site

    RECRUITING

    Toronto, Ontario, M2J 1V1, Canada

  • Clinical Trial Site

    RECRUITING

    Hořovice, Central Bohemia, 26831, Czechia

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Liberec, Liberec Region, 46001, Czechia

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Olomouc, Olomouc Region, 77900, Czechia

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Prague, Prague, 150 06, Czechia

  • Clinical Trial Site

    RECRUITING

    Zlín, Zlín, 762 75, Czechia

  • Clinical Trial Site

    RECRUITING

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69310, France

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Brest, Brittany Region, 29609, France

  • Clinical Trial Site

    RECRUITING

    Plérin, Brittany Region, 22190, France

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Besançon, Doubs, 25000, France

  • Clinical Trial Site

    RECRUITING

    Montpellier, Hérault, 34070, France

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Toulouse, Occitanie, 31059, France

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France

  • Clinical Trial Site

    RECRUITING

    Bobigny, 93000, France

  • Clinical Trial Site

    RECRUITING

    Villejuif, Île-de-France Region, 94805, France

  • Clinical Trial Site

    RECRUITING

    Frankfurt, Hassen, 60431, Germany

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40235, Germany

  • Clinical Trial Site

    RECRUITING

    Witten, North Rhine-Westphalia, 58452, Germany

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Torgau, Saxony, 04860, Germany

  • Clinical Trial Site

    RECRUITING

    Pátrai, Achaia, 26504, Greece

  • Clinical Trial Site

    RECRUITING

    Athens, Attica, 11528, Greece

  • Clinical Trial Site

    RECRUITING

    Athens, Pireas, 18547, Greece

  • Clinical Trial Site

    RECRUITING

    Thessaloniki, Thessaloniki, 57001, Greece

  • Clinical Trial Site

    RECRUITING

    Hong Kong, Hong Kong, 999077, Hong Kong

  • Clinical Trial Site

    RECRUITING

    Hong Kong, Kowloon, 999077, Hong Kong

  • Clinical Trial Site

    RECRUITING

    Hong Kong, Pok Fu Lam, 999077, Hong Kong

  • Clinical Trial Site

    RECRUITING

    Kecskemét, Bács-Kiskun county, 6000, Hungary

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Győr, Győr-Moson-Sopron, 9024, Hungary

  • Clinical Trial Site

    RECRUITING

    Debrecen, Hajdú-Bihar, 4032, Hungary

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Szekszárd, Tolna County, 7100, Hungary

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Petah Tikva, Central District, 4941492, Israel

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Jerusalem, Jerusalem, 91999, Israel

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Ashdod, Southern District, 7747629, Israel

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Naples, Campania, 80131, Italy

  • Clinical Trial Site

    RECRUITING

    Bologna, Emilia-Romagna, 40138, Italy

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Aviano, Friuli Venezia Giulia, 33081, Italy

  • Clinical Trial Site

    RECRUITING

    Rome, Lazio, 00168, Italy

  • Clinical Trial Site

    RECRUITING

    Genoa, Liguria, 16132, Italy

  • Clinical Trial Site

    RECRUITING

    Bergamo, Lombardy, 24127, Italy

  • Clinical Trial Site

    RECRUITING

    Milan, Lombardy, 20141, Italy

  • Clinical Trial Site

    RECRUITING

    Monza, Lombardy, 20900, Italy

  • Clinical Trial Site

    RECRUITING

    Milan, Milano, 20132, Italy

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Pisa, Tuscany, 56126, Italy

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Prato, Tuscany, 59100, Italy

  • Clinical Trial Site

    RECRUITING

    Milan, Varese, 21100, Italy

  • Clinical Trial Site

    RECRUITING

    Ipoh, Ipoh Perak, 30450, Malaysia

  • Clinical Trial Site

    RECRUITING

    Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

  • Clinical Trial Site

    RECRUITING

    Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

  • Clinical Trial Site

    RECRUITING

    George Town, Pulau Pinang, 10450, Malaysia

  • Clinical Trial Site

    RECRUITING

    Kota Kinabalu, Sabah, 88996, Malaysia

  • Clinical Trial Site

    RECRUITING

    Kuching, Sarawak, 93586, Malaysia

  • Clinical Trial Site

    RECRUITING

    Petaling Jaya, Selangor, 46050, Malaysia

  • Clinical Trial Site

    RECRUITING

    Putrajaya, Wilayah PE, 62250, Malaysia

  • Clinical Trial Site

    RECRUITING

    Apeldoorn, Gelderland, 7334 DZ, Netherlands

  • Clinical Trial Site

    RECRUITING

    Maastricht, Limberg, 6202 AZ, Netherlands

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Amsterdam, North Holland, 1081 HV, Netherlands

  • Clinical Trial Site

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 31-826, Poland

  • Clinical Trial Site

    RECRUITING

    Warsaw, Masovian Voivodeship, 03-411, Poland

  • Clinical Trial Site

    RECRUITING

    Otwock, Mazowieckir, 05-400, Poland

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

  • Clinical Trial Site

    RECRUITING

    Rzeszów, Podkarpackie Voivodeship, 35-922, Poland

  • Clinical Trial Site

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Brzozów, Woj Podkarpackie, 36-200, Poland

  • Clinical Trial Site

    RECRUITING

    Lodz, Łódź Voivodeship, 90-302, Poland

  • Clinical Trial Site

    RECRUITING

    Lisbon, Lisbon District, 1099-023, Portugal

  • Clinical Trial Site

    RECRUITING

    Porto, Porto District, 4200-072, Portugal

  • Clinical Trial Site

    RECRUITING

    Porto, Porto District, 4464-513, Portugal

  • Clinical Trial Site

    RECRUITING

    Bucharest, Bucharest, 11171, Romania

  • Clinical Trial Site

    RECRUITING

    Cluj-Napoca, Cluj, 400641, Romania

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Ovidiu, Constanța County, 905900, Romania

  • Clinical Trial Site

    RECRUITING

    Craiova, Dolj, 200542, Romania

  • Clinical Trial Site

    RECRUITING

    Iași, Iaşi, 700106, Romania

  • Clinical Trial Site

    RECRUITING

    Timișoara, Timiș County, 300239, Romania

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Busan, Busan Metropolitan City, 49201, South Korea

  • Clinical Trial Site

    RECRUITING

    Daegu, Daegu Metropolitan City, 41404, South Korea

  • Clinical Trial Site

    RECRUITING

    Goyang-si, Gyeonggi-do, 10408, South Korea

  • Clinical Trial Site

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Clinical Trial Site

    RECRUITING

    Suwon, Gyeonggi-do, 16247, South Korea

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Yongin-si, Gyeonggi-do, 16499, South Korea

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Seoul, Seoul, 02841, South Korea

  • Clinical Trial Site

    RECRUITING

    Seoul, Seoul, 03722, South Korea

  • Clinical Trial Site

    RECRUITING

    Seoul, Seoul Special City, 05505, South Korea

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Seoul, Seoul Special City, 08308, South Korea

  • Clinical Trial Site

    RECRUITING

    Alicante, Alicante, 3010, Spain

  • Clinical Trial Site

    RECRUITING

    Barcelona, Barcelona, 08028, Spain

  • Clinical Trial Site

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Clinical Trial Site

    RECRUITING

    Barcelona, Barcelona, 08036, Spain

  • Clinical Trial Site

    RECRUITING

    Granada, Granada, 18012, Spain

  • Clinical Trial Site

    RECRUITING

    León, León, 24071, Spain

  • Clinical Trial Site

    RECRUITING

    Lleida, Lleida, 25198, Spain

  • Clinical Trial Site

    RECRUITING

    Madrid, Madrid, 28007, Spain

  • Clinical Trial Site

    RECRUITING

    Madrid, Madrid, 28040, Spain

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Madrid, Madrid, 28046, Spain

  • Clinical Trial Site

    RECRUITING

    Madrid, Madrid, 28050, Spain

  • Clinical Trial Site

    RECRUITING

    Murcia, Murcia, 30120, Spain

  • Clinical Trial Site

    RECRUITING

    Seville, Sevilla, 41009, Spain

  • Clinical Trial Site

    RECRUITING

    Valencia, Valencia, 46010, Spain

  • Clinical Trial Site

    RECRUITING

    Zaragoza, Zaragoza, 50009, Spain

  • Clinical Trial Site

    RECRUITING

    Chang-hua, Chang Hua, 50006, Taiwan

  • Clinical Trial Site

    RECRUITING

    Kaohsiung City, Sanmin, 80756, Taiwan

  • Clinical Trial Site

    RECRUITING

    Taipei, Special Municipality, 11217, Taiwan

  • Clinical Trial Site

    RECRUITING

    Taipei, Special Municipality, 11490, Taiwan

  • Clinical Trial Site

    RECRUITING

    Taipei, Taipei City, 100, Taiwan

  • Clinical Trial Site

    RECRUITING

    Taipei, Taipei City, 10449, Taiwan

  • Clinical Trial Site

    RECRUITING

    Bangkok, Bangkok, 10700, Thailand

  • Clinical Trial Site

    RECRUITING

    Dusit, Bangkok, 10300, Thailand

  • Clinical Trial Site

    RECRUITING

    Ban Phaeo, Changwat Samut Sakhon, 74120, Thailand

  • Clinical Trial Site

    RECRUITING

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • Clinical Trial Site

    RECRUITING

    Chiang Mai, Chiang Mai, 50200, Thailand

  • Clinical Trial Site

    RECRUITING

    Brighton, England, BN2 5BE, United Kingdom

  • Clinical Trial Site

    RECRUITING

    London, England, WC1E 6AG, United Kingdom

  • Clinical Trial Site

    RECRUITING

    London, Greater London, EC1M 6BQ, United Kingdom

  • Clinical Trial Site

    RECRUITING

    Taunton, Somerset, TA1 5DA, United Kingdom

  • Clinical Trial Site

    RECRUITING

    Guildford, Surrey, GU2 7XX, United Kingdom

  • Clinical Trial Site

    ACTIVE_NOT_RECRUITING

    Cardiff, Wales, CF14 2TL, United Kingdom

  • Clinical Trial Site 1

    RECRUITING

    Seoul, Seoul, 03080, South Korea

  • Clinical Trial Site 2

    RECRUITING

    Seoul, Seoul, 03080, South Korea

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