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Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
Sponsor: Olema Pharmaceuticals, Inc.
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2025-11-03
Completion Date
2032-01
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
Palazestrant
Participants will be treated with palazestrant 90 mg once daily on a 4-week (28-day) cycle.
Letrozole-matching placebo
Participants will be treated with letrozole-matching placebo once daily on a 4-week (28 day) cycle
Ribociclib
Participants will be treated with ribociclib 600 mg once daily on Days 1-21 of a 4-week (28 day) cycle.
Letrozole
Participants will be treated with letrozole 2.5 mg once daily on a 4-week (28-day) cycle
Palazestrant matching-placebo
Participants will be treated with palazestrant-matching placebo once daily on a 4-week (28-day) cycle
Locations (35)
Clinical Trial Site
Denver, Colorado, United States
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Ames, Iowa, United States
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Scarborough, Maine, United States
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Kansas City, Missouri, United States
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Santa Fe, New Mexico, United States
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Columbus, Ohio, United States
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Sayre, Pennsylvania, United States
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Tennessee City, Tennessee, United States
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Salt Lake City, Utah, United States
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Olympia, Washington, United States
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Sydney, New South Wales, Australia
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Waratah, New South Wales, Australia
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South Brisbane, Queensland, Australia
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Adelaide, South Australia, Australia
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Clayton, Victoria, Australia
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Geelong, Victoria, Australia
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Heidelberg, Victoria, Australia
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Nedlands, Western Australia, Australia
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Toronto, Ontario, Canada
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Hong Kong, Hong Kong, Hong Kong
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Hong Kong, Kowloon, Hong Kong
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Hong Kong, Pok Fu Lam, Hong Kong
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Kuching, Sarawak, Malaysia
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Apeldoorn, Gelderland, Netherlands
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Seoul, Seoul, South Korea
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Seoul, Seoul, South Korea
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Chang-hua, Chang Hua, Taiwan
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Kaohsiung City, Sanmin, Taiwan
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Bangkok, Bangkok, Thailand
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Dusit, Bangkok, Thailand
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Ban Phaeo, Changwat Samut Sakhon, Thailand
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Hat Yai, Changwat Songkhla, Thailand
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Chiang Mai, Chiang Mai, Thailand
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Brighton, England, United Kingdom
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London, England, United Kingdom