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)

Status: Recruiting
Location: See all (190) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult female or male participants.

• ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.

• Evaluable disease (measurable disease or bone-only disease).

• Previously received a CDK4/6 inhibitor in combination with an endocrine therapy in the advanced setting. One additional line of ET as a monotherapy is allowed. Duration of the most recent prior ET must be at least 6 months.

• 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.

Locations
United States
Arizona
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Tucson
California
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Fountain Valley
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La Jolla
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Los Angeles
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Whittier
Colorado
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Aurora
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Denver
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Golden
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Grand Junction
Connecticut
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Danbury
Delaware
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Newark
Florida
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Jacksonville
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Margate
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Orlando
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Plantation
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Tamarac
Georgia
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Atlanta
Illinois
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Chicago
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Chicago
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Urbana
Louisiana
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Baton Rouge
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New Orleans
Massachusetts
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Boston
Maryland
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Baltimore
Michigan
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Detroit
Minnesota
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Saint Louis Park
Nebraska
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Lincoln
New Mexico
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Farmington
New York
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New York
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Port Jefferson Station
Ohio
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Dayton
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Toledo
Oregon
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Portland
Pennsylvania
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Sayre
Tennessee
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Nashville
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Nashville
Texas
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Dallas
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Dallas
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Houston
Utah
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Ogden
Washington
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Spokane
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Spokane
Other Locations
Argentina
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Bahía Blanca
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ACTIVE_NOT_RECRUITING
Buenos Aires
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Córdoba
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Córdoba
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La Rioja
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Mar Del Plata
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Mar Del Plata
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Rosario
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Rosario
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San Miguel De Tucumán
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San Salvador De Jujuy
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Viedma
Australia
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Adelaide
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Ballarat Central
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Clayton
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Gosford
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Nedlands
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Shepparton
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Westmead
Belgium
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Charleroi
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Edegem
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Leuven
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Woluwe-saint-lambert
Brazil
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Belo Horizonte
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Itajaí
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Porto Alegre
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Porto Alegre
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Recife
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Rio De Janeiro
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Salvador
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Sorocaba
Bulgaria
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Panagyurishte
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Sofia
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Vratsa
Canada
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Calgary
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London
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Montreal
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Toronto
France
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Besançon
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Bourg-en-bresse
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Clermont-ferrand
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Compiègne
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Le Mans
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Montpellier
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Nantes
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Villejuif
Germany
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Dresden
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Karlsruhe
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Kiel
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Krefeld
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Velbert
Hong Kong Special Administrative Region
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Central
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Central
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Hong Kong
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Hong Kong
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Kowloon
Hungary
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Debrecen
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Kecskemét
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Pécs
Italy
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Alessandria
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Avellino
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Bologna
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Meldola
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Milan
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Modena
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Pavia
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Reggio Emilia
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Rome
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Rome
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Rozzano
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Udine
Malaysia
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George Town
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Ipoh
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Kota Bharu
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Kuala Lumpur
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Kuching
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Petaling Jaya
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Putrajaya
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Sungai Petani
Mexico
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Monterrey
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Oaxaca City
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Sinaloa
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Zapopan
Netherlands
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Amsterdam
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Rotterdam
Poland
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Brzozów
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Gdynia
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Krakow
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Lodz
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Lublin
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Otwock
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Rzeszów
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Skórzewo
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Wroclaw
Portugal
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Coimbra
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Lisbon
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Lisbon
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Matosinhos Municipality
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Porto
Puerto Rico
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Mayagüez
Republic of Korea
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Busan
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Seoul
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Seoul
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Seoul
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Seoul
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Seoul
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Seoul
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Seoul
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Suwon
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Suwon
Romania
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Brasov
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Bucharest
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Cluj-napoca
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Craiova
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Iași
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Oradea
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Timișoara
Spain
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Alicante
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Badajoz
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Girona
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León
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Lleida
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Madrid
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Madrid
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Pamplona
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Santiago De Compostela
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Seville
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Valencia
Taiwan
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Changhua
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Kaohsiung City
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Taichung
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Taichung
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Tainan
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Taipei
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Taipei
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Taipei
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Taipei
Thailand
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Bangkok
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Bangkok
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Bangkok
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Chiang Mai
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Samut Sakhon
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Songkhla
United Kingdom
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Bodelwyddan
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Leicester
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London
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Nottingham
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Taunton
Contact Information
Primary
Olema Pharmaceuticals, Inc.
OPERA-01@olema.com
415-651-7206
Time Frame
Start Date: 2023-11-16
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 510
Treatments
Experimental: Palazestrant (OP-1250)
Participants will receive Palazestrant
Active_comparator: Standard of Care Endocrine Therapy
Participants will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)
Related Therapeutic Areas
Sponsors
Leads: Olema Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov