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A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)

Status: Recruiting
Location: See all (84) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.

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 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.

Locations
United States
Arkansas
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Hot Springs
California
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Santa Barbara
Colorado
Clinical Trial Site
RECRUITING
Denver
Iowa
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Ames
Illinois
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Peoria
Maryland
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Annapolis
Maine
Clinical Trial Site
RECRUITING
Scarborough
Missouri
Clinical Trial Site
RECRUITING
Kansas City
New Mexico
Clinical Trial Site
RECRUITING
Santa Fe
Ohio
Clinical Trial Site
RECRUITING
Columbus
Pennsylvania
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Horsham
Clinical Trial Site
RECRUITING
Sayre
Tennessee
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Knoxville
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Tennessee City
Texas
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Denton
Clinical Trial Site
ACTIVE_NOT_RECRUITING
El Paso
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Houston
Clinical Trial Site
ACTIVE_NOT_RECRUITING
San Antonio
Utah
Clinical Trial Site
NOT_YET_RECRUITING
Salt Lake City
Washington
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Olympia
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Vancouver
Other Locations
Australia
Clinical Trial Site
RECRUITING
Adelaide
Clinical Trial Site
RECRUITING
Clayton
Clinical Trial Site
RECRUITING
Geelong
Clinical Trial Site
RECRUITING
Heidelberg
Clinical Trial Site
RECRUITING
Nedlands
Clinical Trial Site
ACTIVE_NOT_RECRUITING
South Brisbane
Clinical Trial Site
RECRUITING
Sydney
Clinical Trial Site
RECRUITING
Waratah
Canada
Clinical Trial Site
RECRUITING
Toronto
France
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Bobigny
Greece
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Athens
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Hong Kong
Clinical Trial Site
RECRUITING
Hong Kong
Italy
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Milan
Malaysia
Clinical Trial Site
RECRUITING
George Town
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Ipoh
Clinical Trial Site
RECRUITING
Kota Kinabalu
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Kuala Lumpur
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Kuala Lumpur
Clinical Trial Site
RECRUITING
Kuching
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Petaling Jaya
Clinical Trial Site
RECRUITING
Putrajaya
Netherlands
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Apeldoorn
Poland
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Brzozów
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Rzeszów
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Rzeszów
Republic of Korea
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Busan
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Daegu
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Goyang-si
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Seongnam-si
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Seoul
Clinical Trial Site
RECRUITING
Seoul
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Seoul
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Seoul
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Seoul
Clinical Trial Site
RECRUITING
Suwon
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Yongin-si
Romania
Clinical Trial Site
RECRUITING
Cluj-napoca
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Iași
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Timișoara
Spain
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Alicante
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Barcelona
Clinical Trial Site
RECRUITING
Barcelona
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Granada
Clinical Trial Site
RECRUITING
Madrid
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Murcia
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Valencia
Taiwan
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Chang-hua
Clinical Trial Site
RECRUITING
Kaohsiung City
Clinical Trial Site
RECRUITING
Taipei
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Taipei
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Taipei
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Taipei
Thailand
Clinical Trial Site
RECRUITING
Ban Phaeo
Clinical Trial Site
RECRUITING
Bangkok
Clinical Trial Site
RECRUITING
Chiang Mai
Clinical Trial Site
RECRUITING
Dusit
Clinical Trial Site
RECRUITING
Hat Yai
United Kingdom
Clinical Trial Site
RECRUITING
Brighton
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Guildford
Clinical Trial Site
ACTIVE_NOT_RECRUITING
London
Clinical Trial Site
ACTIVE_NOT_RECRUITING
London
Contact Information
Primary
Olema Pharmaceuticals, Inc.
OPERA-02@olema.com
415-651-7206
Time Frame
Start Date: 2025-11-03
Estimated Completion Date: 2032-01
Participants
Target number of participants: 1000
Treatments
Experimental: Palazestrant
Participants will receive palazestrant, ribociclib and letrozole-matching placebo
Active_comparator: Letrozole
Participants will receive letrozole, ribociclib and palazestrant-matching placebo
Related Therapeutic Areas
Sponsors
Leads: Olema Pharmaceuticals, Inc.
Collaborators: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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