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NCT07085767 · ClinicalTrials.gov registry record · Phase 3
Palazestrant in Combination With Ribociclib for the First-line 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
- 1,000
- Enrollment target
- 20
- Study locations
NCT07085767 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 1,000 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 17 states.
The verdict
NCT07085767, 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
- 1,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Ribociclib
- DRUG Palazestrant
- DRUG Letrozole-matching placebo
- DRUG Palazestrant matching-placebo
Study Locations (20)
Victoria
- Clinical Trial Site - Clayton
- Clinical Trial Site - Geelong
- Clinical Trial Site - Heidelberg
New South Wales
- Clinical Trial Site - Sydney
- Clinical Trial Site - Waratah
Colorado
- Clinical Trial Site - Denver
Iowa
- Clinical Trial Site - Ames
Maine
- Clinical Trial Site - Scarborough
Missouri
- Clinical Trial Site - Kansas City
New Mexico
- Clinical Trial Site - Santa Fe
Ohio
- Clinical Trial Site - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2025-11-03 |
| Est. Completion | 2032-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07085767
The ClinicalTrials.gov registry entry for NCT07085767 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (64% 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 Letrozole is the first listed.
NCT07085767 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Victoria, New South Wales, Colorado.
Frequently Asked Questions
What is clinical trial NCT07085767 about?
NCT07085767 is a clinical study titled "Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer". This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
What is the current status of trial NCT07085767?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2025-11-03. Estimated completion is 2032-01.
What conditions does trial NCT07085767 study?
This clinical trial studies the following conditions: Breast Cancer, Metastatic Breast Cancer, HER2-Negative Breast Carcinoma, ER Positive Breast Cancer, Locally Advanced Breast Cancer.
What interventions are being tested in trial NCT07085767?
The interventions under investigation include: Letrozole (DRUG), Ribociclib (DRUG), Palazestrant (DRUG), Letrozole-matching placebo (DRUG), Palazestrant matching-placebo (DRUG).
Who is sponsoring clinical trial NCT07085767?
This trial is sponsored by Olema Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07085767 being conducted?
This trial has 20 study locations across Colorado, Iowa, Maine, Missouri, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.