Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
NCT ID: NCT07085767
Last Updated: 2026-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1000 participants
INTERVENTIONAL
2025-11-03
2032-01-31
Brief Summary
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Detailed Description
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This trial is seeking adult participants with ER+, HER2- advanced breast cancer who have not received prior systemic anti-cancer treatment for advanced disease. Approximately 1,000 participants will be randomized in a 1:1 ratio to one of the two study arms.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Palazestrant
Participants will receive palazestrant, ribociclib and letrozole-matching placebo
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 receive letrozole, ribociclib and palazestrant-matching placebo
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.
* Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.
* History of allergic reactions to study treatment.
* Any contraindications to letrozole and ribociclib.
* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Olema Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director, MD
Role: STUDY_DIRECTOR
Olema Pharmaceuticals, Inc.
Locations
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Clinical Trial Site
Ames, Iowa, United States
Clinical Trial Site
Scarborough, Maine, United States
Clinical Trial Site
Kansas City, Missouri, United States
Clinical Trial Site
Santa Fe, New Mexico, United States
Clinical Trial Site
Columbus, Ohio, United States
Clinical Trial Site
Sayre, Pennsylvania, United States
Clinical Trial Site
Tennessee City, Tennessee, United States
Clinical Trial Site
Salt Lake City, Utah, United States
Clinical Trial Site
Sydney, New South Wales, Australia
Clinical Trial Site
Waratah, New South Wales, Australia
Clinical Trial Site
South Brisbane, Queensland, Australia
Clinical Trial Site
Adelaide, South Australia, Australia
Clinical Trial Site
Clayton, Victoria, Australia
Clinical Trial Site
Geelong, Victoria, Australia
Clinical Trial Site
Nedlands, Western Australia, Australia
Clinical Trial Site
Hong Kong, Kowloon, Hong Kong
Clinical Trial Site
Hong Kong, Pok Fu Lam, Hong Kong
Clinical Trial Site
Kaohsiung City, Sanmin, Taiwan
Clinical Trial Site
Chang-hua, , Taiwan
Clinical Trial Site
Dusit, Bangkok, Thailand
Clinical Trial Site
Ban Phaeo, Changwat Samut Sakhon, Thailand
Clinical Trial Site
Hat Yai, Changwat Songkhla, Thailand
Countries
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Central Contacts
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Related Links
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Olema Publications
Other Identifiers
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OPERA-02
Identifier Type: OTHER
Identifier Source: secondary_id
OP-1250-302
Identifier Type: -
Identifier Source: org_study_id
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