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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: Recruiting Phase 3 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Olema Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To compare PFS, based on a local investigator assessment, between investigational (palazestrant with ribociclib + letrozole-matching placebo) and control (letrozole with ribociclib + palazestrant-matching placebo) arms.
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 |
What NCT07085767 shows while recruiting
NCT07085767 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (64% lower).
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 names 20 study sites across 17 states, led by 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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07085767's enrollment target sits among peer trials
1,000 120th of 1224 higher than 1,097 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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