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NCT06016738 · ClinicalTrials.gov registry record · Phase 3
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
A Phase 3 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Olema Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 510
- Enrollment target
- 20
- Study locations
NCT06016738 is a Phase 3 study of Breast Cancer and Metastatic Breast Cancer that is actively recruiting participants, run by Olema Pharmaceuticals. The registered enrollment target is 510 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT06016738, a Phase 3 study of Breast Cancer and Metastatic Breast Cancer, is actively recruiting participants, sponsored by Olema Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 510 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Anastrozole
- DRUG Letrozole
- DRUG Exemestane
- DRUG Fulvestrant
- DRUG Palazestrant
Study Locations (20)
California
- Clinical Trial Site - Fountain Valley
- Clinical Trial Site - Glendale
- Clinical Trial Site - La Jolla
- Clinical Trial Site - Los Alamitos
- Clinical Trial Site - Los Angeles
- Clinical Trial Site - Whittier
Florida
- Clinical Trials Site - Jacksonville
- Clinical Trial Site - Margate
- Clinical Trial Site - Orlando
- Clinical Trial Site - Plantation
- Clinical Trial Site - Tamarac
Colorado
- Clinical Trial Site - Aurora
- Clinical Trial Site - Denver
- Clinical Trial Site - Golden
- Clinical Trial Site - Grand Junction
Arizona
- Clinical Trial Site - Tucson
Connecticut
- Clinical Trial Site - Danbury
Delaware
- Clinical Trial Site - Newark
Georgia
- Clinical Trial Site - Atlanta
Illinois
- Clinical Trial Site - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 510 participants |
| Start Date | 2023-11-16 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06016738
The ClinicalTrials.gov registry entry for NCT06016738 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 510 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (82% lower). The listed sponsor is Olema Pharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Anastrozole is the first listed.
NCT06016738 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT06016738 about?
NCT06016738 is a clinical study titled "OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer". 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.
What is the current status of trial NCT06016738?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 510 participants. The study started on 2023-11-16. Estimated completion is 2027-09-30.
What conditions does trial NCT06016738 study?
This clinical trial studies the following conditions: Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, HER2-Negative Breast Carcinoma, ER Positive Breast Cancer.
What interventions are being tested in trial NCT06016738?
The interventions under investigation include: Anastrozole (DRUG), Letrozole (DRUG), Exemestane (DRUG), Fulvestrant (DRUG), Palazestrant (DRUG).
Who is sponsoring clinical trial NCT06016738?
This trial is sponsored by Olema Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06016738 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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