Clinical Trial: NCT06016738
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Olema Pharmaceuticals, Inc. |
| Information Provided By: | Olema Pharmaceuticals, Inc. |
| Last Update Posted: | 2026-08-13 |
Study Overview
Brief Summary
This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.
Official 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)
Conditions
Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma
Intervention / Treatment
- Drug: Palazestrant
- Drug: Fulvestrant
- Drug: Anastrozole
- Drug: Letrozole
- Drug: Exemestane
Other Study ID Numbers
- OP-1250-301
- OPERA-01
Start Date (Actual)
2023-11-16
Primary Completion Date (Estimated)
2026-10-31
Study Completion Date (Estimated)
2028-02-29
Enrollment (Estimated)
510
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Olema Pharmaceuticals, Inc. |
| Information Provided By: | Olema Pharmaceuticals, Inc. |
| Last Update Posted: | 2026-08-13 |
Study Overview
Brief Summary
This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.
Official 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)
Conditions
Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma
Intervention / Treatment
- Drug: Palazestrant
- Drug: Fulvestrant
- Drug: Anastrozole
- Drug: Letrozole
- Drug: Exemestane
Other Study ID Numbers
- OP-1250-301
- OPERA-01
Start Date (Actual)
2023-11-16
Primary Completion Date (Estimated)
2026-10-31
Study Completion Date (Estimated)
2028-02-29
Enrollment (Estimated)
510
Study Type
Interventional
Phase
Phase 3