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: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 31 Oct 2025

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At a glance

Drugs Alpelisib (Primary) ; Atirmociclib (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

31 Oct 2025 Last checked against ClinicalTrials.gov: US National Institutes of Health record.
20 Oct 2025 Planned number of patients changed from 155 to 190.
20 Oct 2025 Planned End Date changed from 9 Aug 2026 to 31 Jan 2028.

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