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

NCT07085767 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-05-15

No results posted yet for this 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

Interventions

DRUG

Palazestrant

Participants will be treated with palazestrant 90 mg once daily on a 4-week (28-day) cycle.

DRUG

Letrozole-matching placebo

Participants will be treated with letrozole-matching placebo once daily on a 4-week (28 day) cycle

DRUG

Ribociclib

Participants will be treated with ribociclib 600 mg once daily on Days 1-21 of a 4-week (28 day) cycle.

DRUG

Letrozole

Participants will be treated with letrozole 2.5 mg once daily on a 4-week (28-day) cycle

DRUG

Palazestrant matching-placebo

Participants will be treated with palazestrant-matching placebo once daily on a 4-week (28-day) cycle

Sponsors & Collaborators

Principal Investigators

  • Medical Director, MD · Olema Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-03
Primary Completion
2028-12-31
Completion
2032-01-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Italy
  • Malaysia
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07085767 on ClinicalTrials.gov