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OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
Sponsor: Olema Pharmaceuticals, Inc.
Summary
This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.
Official title: A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
510
Start Date
2023-11-16
Completion Date
2028-02-29
Last Updated
2026-08-13
Healthy Volunteers
No
Conditions
Interventions
Palazestrant
Participants will be treated with palazestrant once daily on a 4 week (28 day) cycle. Doses evaluated in the dose-selection part will be 120 mg once daily and 90 mg once daily.
Fulvestrant
Participants will be treated with fulvestrant on C1D1, C1D15, and then on Day 1 of every subsequent 4 week (28 day) cycle
Anastrozole
Participants will be treated with anastrozole once daily on a 4 week (28 day) cycle
Letrozole
Participants will be treated with letrozole once daily on a 4 week (28 day) cycle
Exemestane
Participants will be treated with exemestane once daily on a 4 week (28 day) cycle
Locations (233)
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Tucson, Arizona, United States
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Fountain Valley, California, United States
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Glendale, California, United States
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La Jolla, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Whittier, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Golden, Colorado, United States
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Grand Junction, Colorado, United States
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Danbury, Connecticut, United States
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Newark, Delaware, United States
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Jacksonville, Florida, United States
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Margate, Florida, United States
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Orlando, Florida, United States
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Plantation, Florida, United States
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Tamarac, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Urbana, Illinois, United States
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Baton Rouge, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Saint Louis Park, Minnesota, United States
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Woodbury, Minnesota, United States
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Lincoln, Nebraska, United States
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Farmington, New Mexico, United States
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New York, New York, United States
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Port Jefferson Station, New York, United States
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Dayton, Ohio, United States
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Toledo, Ohio, United States
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Portland, Oregon, United States
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Sayre, Pennsylvania, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Webster, Texas, United States
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Ogden, Utah, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Bahía Blanca, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Córdoba, Córdoba Province, Argentina
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San Salvador de Jujuy, Jujuy Province, Argentina
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La Rioja, La Rioja Province, Argentina
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Viedma, Río Negro Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Buenos Aires, Argentina
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Gosford, New South Wales, Australia
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Westmead, New South Wales, Australia
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Adelaide, South Australia, Australia
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Ballarat Central, Victoria, Australia
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Clayton, Victoria, Australia
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Shepparton, Victoria, Australia
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Nedlands, Western Australia, Australia
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Wels, Austria
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Wiener Neustadt, Austria
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Edegem, Antwerpen, Belgium
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Wilrijk, Antwerpen, Belgium
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Woluwe-Saint-Lambert, Brussels Capital, Belgium
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Charleroi, Hainaut, Belgium
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Leuven, Vlaams Brabant, Belgium
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Salvador, Estado de Bahia, Brazil
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Brasília, Federal District, Brazil
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São Luís, Maranhão, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Curitiba, Paraná, Brazil
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Recife, Pernambuco, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Itajaí, Santa Catarina, Brazil
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Jaú, São Paulo, Brazil
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Sorocaba, São Paulo, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Panagyurishte, Pazardzhik, Bulgaria
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Sofia, Sofia-Grad, Bulgaria
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Vratsa, Vratsa, Bulgaria
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Calgary, Alberta, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Hradec Králové, Hradec Králové Region, Czechia
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Nový Jičín, Moravian-Silesian Region, Czechia
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Olomouc, Olomouc Region, Czechia
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Brno, Czechia
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Prague, Czechia
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Bourg-en-Bresse, Ain, France