NCT07085767Phase 3Recruiting

Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

Study sponsor: Olema Pharmaceuticals, Inc. · OLMA

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2028-12Estimated

Enrollment · participants1000Estimated

Source updated2026-09-23Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-12-02 · 1 field changed

Recruitment status

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Recruiting

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Study details

Conditions studied

Breast Cancer; Locally Advanced Breast Cancer; Metastatic Breast Cancer; ER Positive Breast Cancer; HER2 Negative Breast Carcinoma

Treatments or interventions studied

PalazestrantDrugAlso known as OP-1250
Letrozole-matching placeboDrug
RibociclibDrug
LetrozoleDrug
Palazestrant matching-placeboDrug

Primary outcomes · main study measures

measure: Progression-Free Survival (PFS); description: To compare PFS, based on a local investigator assessment, between investigational (palazestrant with ribociclib + letrozole-matching placebo) and control (letrozole with ribociclib + palazestrant-matching placebo) arms.; timeFrame: From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 3.5 years)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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