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

NCT07085767

RecruitingPhase 3

Sponsor: Olema Pharmaceuticals, Inc.

Conditions: Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma

Interventions: Palazestrant, Letrozole-matching placebo, Ribociclib, Letrozole, Palazestrant matching-placebo

Countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion 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 CDK4/6 inhibitors)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate hematologic, hepatic, and renal functions.
* Female participants can be pre-, peri- or postmenopausal.
* Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.

Exclusion Criteria:

* Disease recurrence during adjuvant endocrine therapy
* Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.
* Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.
* History of allergic reactions to study treatment.
* Any contraindications to letrozole and ribociclib.
* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
Locations (167)
  • Hot Springs, Arkansas, United States
  • Beverly Hills, California, United States
  • La Jolla, California, United States
  • Los Alamitos, California, United States
  • San Francisco, California, United States
  • Santa Barbara, California, United States
  • Aurora, Colorado, United States
  • Denver, Colorado, United States
  • New Haven, Connecticut, United States
  • Tampa, Florida, United States
  • Marietta, Georgia, United States
  • Honolulu, Hawaii, United States
  • Peoria, Illinois, United States
  • Urbana, Illinois, United States
  • Ames, Iowa, United States
  • Scarborough, Maine, United States
  • Annapolis, Maryland, United States
  • Minneapolis, Minnesota, United States
  • Jackson, Mississippi, United States
  • Kansas City, Missouri, United States
  • Santa Fe, New Mexico, United States
  • New York, New York, United States
  • Charlotte, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Columbus, Ohio, United States
  • Horsham, Pennsylvania, United States
  • Sayre, Pennsylvania, United States
  • Bartlett, Tennessee, United States
  • Knoxville, Tennessee, United States
  • Mount Juliet, Tennessee, United States
  • + 137 more on CT.gov