NCT07085767 - Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer | Biotech Hunter

Enrollment

1,000

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

January 31, 2032

Conditions

Breast CancerLocally Advanced Breast CancerMetastatic Breast CancerER Positive Breast CancerHER2 Negative Breast Carcinoma

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

Trial Locations (10)

3168

Clinical Trial Site, Clayton

5000

Clinical Trial Site, Adelaide

6009

Clinical Trial Site, Nedlands

18840

Clinical Trial Site, Sayre

37203

Clinical Trial Site, Tennessee City

50010

Clinical Trial Site, Ames

64132

Clinical Trial Site, Kansas City

84106

Clinical Trial Site, Salt Lake City

87505

Clinical Trial Site, Santa Fe

04074

Clinical Trial Site, Scarborough