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Clinical trial

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)

NCT06016738 is registered in ClinicalTrials.gov with Olema Pharmaceuticals, Inc. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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)
Lead sponsor
Olema Pharmaceuticals, Inc.
Phase
Phase 3
Overall status
Active, not recruiting
Start date
November 16, 2023
Completion date
February 29, 2028
Enrollment
510 (estimated)
Sites
233

Conditions

As the registry lists them; a condition with its own page is linked.

advanced breast cancer, breast cancer, er positive breast cancer, her2 negative breast carcinoma, metastatic breast cancer