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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

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

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

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

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.

Eligibility

Primary outcome measure(s)

• Progression-Free Survival (PFS) — From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 3.5 years)
  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.

Trial sites (181)

+ 141 more sites — see the full list on the official registry below.