Trial: OP-1250 (Palazestrant) vs. Standard of …

Trial Details

Sponsor: Olema Pharmaceuticals, Inc. (industry)

Phase: 3

Start date: Nov. 16, 2023

Planned enrollment: 510

Trial ID: NCT06016738

More trial details at ClinicalTrials.gov

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: Palazestrant (OP-1250)

Overview

Palazestrant (OP-1250) is an investigational oral treatment for estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer. Human results are available from an open-label phase 1/2 monotherapy study and an early-phase study combining it with ribociclib. The reported efficacy results are not yet a comparison against standard treatment. (link.springer.com)

Mechanism of action

Palazestrant targets the estrogen receptor. It is designed to block both of the receptor’s transcriptional activation domains (AF1 and AF2) and promote receptor degradation. Preclinical studies found activity against receptors with and without ESR1 mutations; whether that translates into a clinical advantage remains to be established. (link.springer.com)

Efficacy

In the published phase 1/2 monotherapy study, 146 patients enrolled. At the 120-mg daily dose, 3 of 66 patients with measurable disease (4.5%) had a confirmed partial response by the study’s data cutoff. The clinical benefit rate was 45.7%, and median progression-free survival was 4.8 months; among patients whose cancers had ESR1 mutations, median progression-free survival was 5.6 months. (link.springer.com)

A 2025 conference poster reported preliminary results for palazestrant plus ribociclib: 15 of 44 response-evaluable patients (34%) had a confirmed complete or partial response. The population included patients both with and without prior CDK4/6-inhibitor treatment, so this rate should not be compared directly with the monotherapy result. (ir.olema.com)

Safety

At 120 mg daily in the monotherapy study, the most common treatment-emergent adverse events were nausea (62.8%), vomiting (29.1%), and fatigue (25.6%); most events were grade 1 or 2. Treatment-related grade 4 neutropenia occurred in 5 of 86 patients (5.8%). In the combination study, neutropenia was also common, but its contribution from each drug cannot be determined from the single-arm results. (link.springer.com)

TrialFetch AI Analysis

Goal: Compare the efficacy and safety of palazestrant monotherapy with standard endocrine therapy after progression on endocrine therapy plus a CDK4/6 inhibitor.

Patients: Adults with ER-positive, HER2-negative locally advanced or metastatic breast cancer not amenable to curative treatment, evaluable disease, and ECOG performance status 0–1. Patients must have received endocrine therapy plus a CDK4/6 inhibitor and may have received one additional endocrine monotherapy line; prior chemotherapy for advanced disease is excluded. Patients with symptomatic visceral disease or an urgent need for treatment beyond endocrine monotherapy are ineligible.

Design: International, multicenter, randomized, open-label, active-controlled study. An initial dose-selection part randomizes approximately 120 participants between two palazestrant doses and standard care; approximately 390 additional participants are then randomized between the selected dose and standard care.

Treatments: Palazestrant (OP-1250) is an investigational oral estrogen receptor–targeted agent designed to inhibit both AF1 and AF2 transcriptional activation and promote receptor degradation. In a noncomparative phase 1/2 monotherapy study, the 120-mg daily dose yielded a 4.5% confirmed partial response rate among 66 patients with measurable disease and a median progression-free survival of 4.8 months; these results do not establish superiority to standard care. The comparator is investigator’s choice of fulvestrant or an aromatase inhibitor (anastrozole, letrozole, or exemestane).

Outcomes: The dose-selection part measures adverse events, palazestrant dose reductions, and discontinuations through 16 weeks. The trial’s primary efficacy outcome is blinded independent review committee–assessed progression-free survival, evaluated separately in patients with and without detected ESR1 mutations, with follow-up estimated at up to 2 years. Overall survival in those populations is a secondary outcome, with follow-up estimated at up to 4 years.

Burden on patient: Likely moderate and broadly comparable to ongoing metastatic breast cancer care: participants will need treatment visits, safety assessments, and imaging to assess progression over potentially several years. Oral palazestrant or an aromatase inhibitor may reduce administration visits relative to injectable fulvestrant. The provided information does not specify scan frequency or require extra biopsies or intensive pharmacokinetic sampling, so the additional testing and travel burden cannot be quantified.

Last updated: Sep 2026

Eligibility

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Westmead, New South Wales, 2145, Australia

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Gosford, New South Wales, 2250, Australia

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Adelaide, South Australia, 5000, Australia

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Shepparton, Victoria, 3630, Australia

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Ballarat Central, Victoria, 3355, Australia

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Clayton, Victoria, 3168, Australia

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Nedlands, Western Australia, 6009, Australia

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Wiener Neustadt, 2700, Austria

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Wels, 4600, 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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Rio de Janeiro, 22281-100, Brazil

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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, 91350-200, 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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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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Panagyurishte, Pazardzhik, 4500, Bulgaria

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Sofia, Sofia-Grad, 1407, Bulgaria

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Calgary, Alberta, T2N 5G2, Canada

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Toronto, Ontario, M5G 1X5, Canada

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London, Ontario, N6A 5W9, Canada

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Montreal, Quebec, H4A 3J1, Canada

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Brno, 625 00, Czechia

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Prague, 140 59, 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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Caen, 14000, France

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Montpellier, 34070, France

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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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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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Hong Kong, 999077, Hong Kong

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Hong Kong, 999077, 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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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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Genova, 16132, Italy

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Padova, 35128, Italy

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Pavia, 27100, Italy

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Avellino, Campania, 83100, Italy

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Meldola, Emilia-Romagna, 47014, Italy

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Bologna, Emilia-Romagna, 40138, Italy

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Modena, Emilia-Romagna, 41124, Italy

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Reggio Emilia, Emilia-Romagna, 42100, 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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Alessandria, Piedmont, 15121, Italy

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Aviano, Pordenone, 33081, Italy

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Sungai Petani, Kedah, 8000, Malaysia

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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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Sinaloa, 80020, Mexico

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Oaxaca City, 68020, Mexico

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Monterrey, 64460, Mexico

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Guadalajara, Jalisco, 44670, Mexico

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San Luis Potosí City, San Luis Potosí, 78209, 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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Krakow, 31-115, Poland

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Krakow, 31-501, Poland

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Poznan, 60-192, Poland

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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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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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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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Seoul, 03722, 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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Suwon, 16499, South Korea

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Seoul, 08308, South Korea

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Seoul, 06591, South Korea

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Seoul, 06273, South Korea

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Seoul, 05505, South Korea

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Suwon, Gyeonggi-do, 16247, South Korea

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Alicante, 03010, Spain

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Santiago de Compostela, 15706, Spain

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Madrid, 28033, Spain

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Fuenlabrada, 28942, Spain

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Santa Cruz de Tenerife, 38320, Spain

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Badajoz, Badajoz, 06080, 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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Valencia, Valencia, 46010, Spain

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Taichung, 40447, Taiwan

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Kaohsiung City, 80756, Taiwan

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Changhua, 500, Taiwan

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Taipei, 114, Taiwan

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Taipei, 11217, Taiwan

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Taipei, 111, Taiwan

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Taipei, 100, Taiwan

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Tainan, 736, Taiwan

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Taichung, 433, Taiwan

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Chiang Mai, 50180, Thailand

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Bangkok, 10330, Thailand

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Bangkok, 10300, Thailand

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Songkhla, 90110, Thailand

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Samut Sakhon, 74120, Thailand

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Bangkok, 10700, Thailand

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London, EC1A 7BE, United Kingdom

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Bodelwyddan, LL18 5UJ, United Kingdom

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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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Tucson, Arizona, 85719, United States

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Whittier, California, 90602, 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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Denver, Colorado, 80218, United States

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Golden, Colorado, 80401, United States

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Aurora, Colorado, 80045, 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, 60637, United States

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Chicago, Illinois, 60616-2315, United States

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Urbana, Illinois, 61801, 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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Dayton, Ohio, 45415, 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, 37208, United States

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Nashville, Tennessee, 37203, United States

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Nashville, Tennessee, 37232, United States

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Webster, Texas, 77598, 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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Ogden, Utah, 84405, United States

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Spokane, Washington, 99208, United States

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