Trial Profile

A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4/6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, or With the mTOR Inhibitor Everolimus in Adult Subjects With Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

Status: Active, no longer recruiting

Phase of Trial: Phase I/II

Latest Information Update: 06 Sep 2025

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At a glance

Drugs Alpelisib (Primary) ; Everolimus (Primary) ; Palazestrant (Primary) ; Ribociclib (Primary)
Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
Focus Adverse reactions; Pharmacokinetics
Sponsors Olema Pharmaceuticals

06 Sep 2025 Last checked against ClinicalTrials.gov: US National Institutes of Health record.
15 Aug 2025 Planned End Date changed from 30 Jun 2026 to 9 Aug 2026.
15 Aug 2025 Planned primary completion date changed from 20 May 2026 to 9 Aug 2026.

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