New hope for advanced breast cancer: OP-1250 faces off against standard care

NCT ID NCT06016738

Ongoing Disease control Sponsor: Olema Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study tests a new drug called OP-1250 (palazestrant) against the usual treatments (fulvestrant or an aromatase inhibitor) in people with a certain type of advanced breast cancer (ER+, HER2-). The goal is to see if OP-1250 can slow cancer growth better than standard care. The study includes 510 adults whose cancer has worsened after previous hormone therapy and a CDK4/6 inhibitor.

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Conditions

The condition(s) this trial relates to.

breast cancer 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.

ADVANCED BREAST CANCER BREAST CANCER ER POSITIVE BREAST CANCER HER2-NEGATIVE BREAST CARCINOMA METASTATIC BREAST CANCER

Contacts and locations

Locations

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Tucson, Arizona, 85719, United States
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Fountain Valley, California, 92708, United States
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Glendale, California, 91204, United States
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La Jolla, California, 92093, United States
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Los Alamitos, California, 90720, United States
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Los Angeles, California, 90027, United States
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Whittier, California, 90602, United States
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Aurora, Colorado, 80045, United States
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Denver, Colorado, 80218, United States
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Golden, Colorado, 80401, United States
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Grand Junction, Colorado, 81505, United States
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Danbury, Connecticut, 06810, United States
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Newark, Delaware, 19713, United States
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Margate, Florida, 33063, United States
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Orlando, Florida, 32804, United States
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Plantation, Florida, 33324, United States
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Tamarac, Florida, 33321, United States
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Atlanta, Georgia, 30322, United States
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Chicago, Illinois, 60616-2315, United States
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Chicago, Illinois, 60637, United States
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Urbana, Illinois, 61801, United States
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Baton Rouge, Louisiana, 70809, United States
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New Orleans, Louisiana, 70112, United States
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Baltimore, Maryland, 21201, United States
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Boston, Massachusetts, 02111, United States
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Detroit, Michigan, 48202, United States
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Saint Louis Park, Minnesota, 55426, United States
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Woodbury, Minnesota, 55125, United States
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Lincoln, Nebraska, 68516, United States
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Farmington, New Mexico, 87401, United States
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New York, New York, 10032, United States
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Port Jefferson Station, New York, 11776, United States
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Dayton, Ohio, 45415, United States
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Toledo, Ohio, 43623, United States
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Portland, Oregon, 97239, United States
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Sayre, Pennsylvania, 18840, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37208, United States
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Nashville, Tennessee, 37232, United States
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Dallas, Texas, 75246, United States
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Dallas, Texas, 75390, United States
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Houston, Texas, 77054, United States
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Webster, Texas, 77598, United States
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Ogden, Utah, 84405, United States
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Spokane, Washington, 99204, United States
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Spokane, Washington, 99208, United States
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Bahía Blanca, Buenos Aires, B8000HXM, Argentina
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Mar del Plata, Buenos Aires, B7600FZN, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Córdoba, Córdoba Province, X5000HHW, Argentina
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Córdoba, Córdoba Province, X5008HHW, Argentina
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San Salvador de Jujuy, Jujuy Province, 4600, Argentina
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La Rioja, La Rioja Province, 5300, Argentina
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Viedma, Río Negro Province, R8500ACE, Argentina
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Rosario, Santa Fe Province, S2013DTC, Argentina
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Rosario, Santa Fe Province, S2013KDS, Argentina
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San Miguel de Tucumán, Tucumán Province, 4000, Argentina
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Buenos Aires, C14626ABP, Argentina
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Gosford, New South Wales, 2250, Australia
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Westmead, New South Wales, 2145, Australia
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Adelaide, South Australia, 5000, Australia
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Ballarat Central, Victoria, 3355, Australia
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Clayton, Victoria, 3168, Australia
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Shepparton, Victoria, 3630, Australia
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Nedlands, Western Australia, 6009, Australia
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Wels, 4600, Austria
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Wiener Neustadt, 2700, Austria
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Edegem, Antwerpen, 2650, Belgium
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Wilrijk, Antwerpen, 2610, Belgium
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Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium
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Charleroi, Hainaut, 6060, Belgium
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Leuven, Vlaams Brabant, Belgium
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Salvador, Estado de Bahia, 41253-190, Brazil
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Brasília, Federal District, 70.390-140, Brazil
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São Luís, Maranhão, 65.060-645, Brazil
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Belo Horizonte, Minas Gerais, 30150-221, Brazil
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Curitiba, Paraná, 81520-060, Brazil
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Recife, Pernambuco, 50070-480, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
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Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
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Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
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Itajaí, Santa Catarina, 88301-220, Brazil
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Jaú, São Paulo, 17210-080, Brazil
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Sorocaba, São Paulo, 18052-775, Brazil
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Porto Alegre, 90470-340, Brazil
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Rio de Janeiro, 22281-100, Brazil
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Panagyurishte, Pazardzhik, 4500, Bulgaria
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Sofia, Sofia-Grad, 1407, Bulgaria
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Vratsa, Vratsa, 3000, Bulgaria
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Calgary, Alberta, T2N 5G2, Canada
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London, Ontario, N6A 5W9, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Hradec Králové, Hradec Králové Region, 500 12, Czechia
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Nový Jičín, Moravian-Silesian Region, 741 01, Czechia
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Olomouc, Olomouc Region, 779 00, Czechia
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Brno, 625 00, Czechia
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Prague, 140 59, Czechia
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Bourg-en-Bresse, Ain, 01000, France
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Besançon, Doubs, 25030, France
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Nantes, Loire-Atlantique, 44277, France
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Nantes, Loire-Atlantique, 44805, France
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Compiègne, Oise, 60200, France
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Clermont-Ferrand, Puy-de-Dôme, 63011, France
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Le Mans, Sarthe, 7200, France
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Villejuif, Val-de-Marne, 94805, France
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Caen, 14000, France
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Montpellier, 34070, France
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Paris, 75014, France
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Karlsruhe, Baden-Wurttemberg, 76135, Germany
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Krefeld, North Rhine-Westphalia, 47805, Germany
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Velbert, North Rhine-Westphalia, 42551, Germany
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Dresden, Saxony, 01307, Germany
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Kiel, Schleswig-Holstein, 24105, Germany
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Central, Hong Kong, 100176, Hong Kong
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Hong Kong, Hong Kong, 999077, Hong Kong
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Kowloon, Hong Kong, 999077, Hong Kong
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Hong Kong, 999077, Hong Kong
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Pécs, Baranya, 7624, Hungary
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Kecskemét, Bács-Kiskun county, 6000, Hungary
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Debrecen, Hajdú-Bihar, 4032, Hungary
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Avellino, Campania, 83100, Italy
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Bologna, Emilia-Romagna, 40138, Italy
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Meldola, Emilia-Romagna, 47014, Italy
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Modena, Emilia-Romagna, 41124, Italy
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Reggio Emilia, Emilia-Romagna, 42100, Italy
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Udine, Friuli Venezia Giulia, 33100, Italy
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Rome, Lazio, 00144, Italy
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Rome, Lazio, 00168, Italy
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Milan, Lombardy, 20141, Italy
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Rozzano, Lombardy, 20089, Italy
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Piacenza, Piacenza, 29121, Italy
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Alessandria, Piedmont, 15121, Italy
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Aviano, Pordenone, 33081, Italy
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Ancona, 60126, Italy
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Genova, 16132, Italy
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Naples, 80131, Italy
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Padova, 35128, Italy
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Pavia, 27100, Italy
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Kota Bharu, Kelantan, 16150, Malaysia
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Ipoh, Perak, 30450, Malaysia
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George Town, Pulau Pinang, 10450, Malaysia
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Putrajaya, Putramya, 62250, Malaysia
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Kuching, Sarawak, 93586, Malaysia
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Petaling Jaya, Selangor, 46050, Malaysia
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Kuala Lumpur, WP, 59100, Malaysia
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Guadalajara, Jalisco, 44670, Mexico
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Mexico City, Mexico City, 06760, Mexico
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Puebla City, Puebla, 72530, Mexico
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San Luis Potosí City, San Luis Potosí, 78209, Mexico
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Monterrey, 64460, Mexico
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Oaxaca City, 68020, Mexico
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Sinaloa, 80020, Mexico
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Amsterdam, North Holland, 1081 HV, Netherlands
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Rotterdam, South Holland, 3083 AN, Netherlands
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Lublin, Lublin Voivodeship, 20-090, Poland
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Lodz, Lódzkie, 93-513, Poland
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Otwock, Masovian Voivodeship, 05-400, Poland
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Brzozów, Podkarpackie Voivodeship, 36-200, Poland
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Rzeszów, Podkarpackie Voivodeship, 35-021, Poland
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Gdynia, Pomeranian Voivodeship, 81-519, Poland
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Gdansk, 80-214, Poland
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Krakow, 31-115, Poland
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Krakow, 31-501, Poland
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Poznan, 60-192, Poland
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Wroclaw, 50-450, Poland
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Coimbra, Coimbra District, 3000-075, Portugal
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Lisbon, Lisbon District, 1099-023, Portugal
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Lisbon, Lisbon District, 1500-458, Portugal
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Porto, Porto District, 4200-072, Portugal
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Senhora da Hora, Porto District, 4464-513, Portugal
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Mayagüez, Puerto Rico, 00682-6391, Puerto Rico
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Oradea, Bihor County, 410469, Romania
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Brasov, Brașov County, 500152, Romania
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Bucharest, Bucharest, 014146, Romania
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Cluj-Napoca, Cluj, 400015, Romania
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Cluj-Napoca, Cluj, 400132, Romania
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Craiova, Dolj, 200542, Romania
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Iași, Iaşi, 700106, Romania
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Timișoara, Timiș County, 300239, Romania
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Bucharest, 030171, Romania
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Iași, 700451, Romania
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Suwon, Gyeonggi-do, 16247, South Korea
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Busan, 49201, South Korea
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Seoul, 02841, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06273, South Korea
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Seoul, 06591, South Korea
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Seoul, 08308, South Korea
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Suwon, 16499, South Korea
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Badajoz, Badajoz, 06080, Spain
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Badalona, Barcelona, 08916, Spain
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Manresa, Barcelona, 08243, Spain
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Girona, Girona, 17007, Spain
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León, León, 24071, Spain
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Lleida, Lleida, 25198, Spain
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Madrid, Madrid, 28050, Spain
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Pamplona, Navarre, 31008, Spain
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Seville, Sevilla, 41009, Spain
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Reus, Tarragona, 43204, Spain
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Valencia, Valencia, 46010, Spain
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Alicante, 03010, Spain
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Barcelona, 08023, Spain
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Fuenlabrada, 28942, Spain
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Madrid, 28033, Spain
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Murcia, 30120, Spain
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Santiago de Compostela, 15706, Spain
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Changhua, 500, Taiwan
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Kaohsiung City, 80756, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 433, Taiwan
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Tainan, 736, Taiwan
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Taipei, 100, Taiwan
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Taipei, 111, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 114, Taiwan
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Bangkok, 10300, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10700, Thailand
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Chiang Mai, 50180, Thailand
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Samut Sakhon, 74120, Thailand
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Songkhla, 90110, Thailand
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Leicester, Leicestershire, LE1 5WW, United Kingdom
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Nottingham, Nottingham, NG5 1PB, United Kingdom
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Taunton, Somerset, TA1 5DA, United Kingdom
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Bodelwyddan, LL18 5UJ, United Kingdom
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London, EC1A 7BE, United Kingdom
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Santa Cruz de Tenerife, 38320, Spain
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Jacksonville, Florida, 32223, United States
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Hong Kong, 999077, Hong Kong
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Sungai Petani, Kedah, 8000, Malaysia

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