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RECRUITING Phase 3

Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

NCT07085767 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,000 participants
Start Date 2025-11-03
Est. Completion 2032-01
Phase Phase 3

Sponsor

Olema Pharmaceuticals

4 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Olema Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07085767 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Victoria, New South Wales, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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, Locally Advanced Breast Cancer, HER2 Negative Breast Carcinoma, ER Positive Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07085767?

This trial is sponsored by Olema Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial