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OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

NCT06016738 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2026-03-13

No results posted yet for this 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

Interventions

DRUG

Palazestrant

Participants will be treated with palazestrant once daily on a 4 week (28 day) cycle. Doses evaluated in the dose-selection part will be 120 mg once daily and 90 mg once daily.

DRUG

Fulvestrant

Participants will be treated with fulvestrant on C1D1, C1D15, and then on Day 1 of every subsequent 4 week (28 day) cycle

DRUG

Anastrozole

Participants will be treated with anastrozole once daily on a 4 week (28 day) cycle

DRUG

Letrozole

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

DRUG

Exemestane

Participants will be treated with exemestane once daily on a 4 week (28 day) cycle

Sponsors & Collaborators

  • Olema Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director, MD · Olema Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-16
Primary Completion
2026-06-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • Puerto Rico
  • Romania
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06016738 on ClinicalTrials.gov