# OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

Source: https://onco.cc/trials/nct06016738/  
OnCo record `nct06016738` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Fulvestrant and Exemestane in HR-positive / HER2-negative breast cancer, run by Olema Pharmaceuticals, Inc., active and no longer recruiting.

## Summary

OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer is a phase 3 interventional study registered as NCT06016738 by Olema Pharmaceuticals, Inc., with 510 participants enrolled, started 2023-11-16 and due to reach its primary completion in 2026-10-31. Interventions recorded: Palazestrant, Fulvestrant, Anastrozole, Letrozole and Exemestane.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT06016738
- Phase: 3
- Setting: A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)
- Sponsor: Olema Pharmaceuticals, Inc.
- Enrolled: 510

## Sources

- ClinicalTrials.gov NCT06016738: https://clinicaltrials.gov/study/NCT06016738

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- drugs: [Exemestane](https://onco.cc/drugs/exemestane/), [Fulvestrant](https://onco.cc/drugs/fulvestrant/)
- companies: [Olema Pharmaceuticals](https://onco.cc/companies/olema-pharmaceuticals/)

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JSON: https://onco.cc/api/v1/entities/nct06016738.json