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.

Trial Details

NCT ID
NCT07085767
Phase
PHASE3
Sponsor
Olema Pharmaceuticals, Inc.
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Palazestrant
  • Letrozole-matching placebo
  • Ribociclib
  • Letrozole
  • Palazestrant matching-placebo
Locations (sample)
  • Hot Springs, Arkansas, United States|34.5037,-93.05518
  • Beverly Hills, California, United States|34.07362,-118.40036
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Honolulu, Hawaii, United States|21.30694,-157.85833
  • Peoria, Illinois, United States|40.69365,-89.58899

Key Eligibility Criteria

  • Adult female or male participants.
  • ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
  • Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).
  • De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/…

For full eligibility, visit ClinicalTrials.gov.

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