Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma
In brief
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.
Key facts
- Study ID
- NCT07085767
- Run by
- Olema Pharmaceuticals, Inc.
- People needed
- 1000
- Starts
- 2025-11-03
- Expected to finish
- 2032-01-01
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Clinical Trial Site — Houston, Texas, United States (enrolling)
- Clinical Trial Site — Waratah, New South Wales, Australia (enrolling)
- Clinical Trial Site — Tennessee City, Tennessee, United States (enrolling)
- Clinical Trial Site — El Paso, Texas, United States (enrolling)
- Clinical Trial Site — Fort Belvoir, Virginia, United States (enrolling)
- Clinical Trial Site — Sydney, New South Wales, Australia (enrolling)
- Clinical Trial Site — Denver, Colorado, United States (enrolling)
- Clinical Trial Site — Bartlett, Tennessee, United States (enrolling)
- Clinical Trial Site — Tampa, Florida, United States (enrolling)
- Clinical Trial Site — Denton, Texas, United States (enrolling)
- Clinical Trial Site — Honolulu, Hawaii, United States (enrolling)
- Clinical Trial Site — Peoria, Illinois, United States (enrolling)
- Clinical Trial Site — Norfolk, Virginia, United States (enrolling)
- Clinical Trial Site — Olympia, Washington, United States (enrolling)
- Clinical Trial Site — Scarborough, Maine, United States (enrolling)
- Clinical Trial Site — Annapolis, Maryland, United States (enrolling)
- Clinical Trial Site — Minneapolis, Minnesota, United States (enrolling)
- Clinical Trial Site — Sayre, Pennsylvania, United States (enrolling)
- Clinical Trial Site — Kansas City, Missouri, United States (enrolling)
- Clinical Trial Site — Santa Fe, New Mexico, United States (enrolling)
- Clinical Trial Site — Marietta, Georgia, United States (enrolling)
- Clinical Trial Site — San Francisco, California, United States (enrolling)
- Clinical Trial Site — Cincinnati, Ohio, United States (enrolling)
- Clinical Trial Site — Columbus, Ohio, United States (enrolling)
- Clinical Trial Site — South Brisbane, Queensland, Australia (enrolling)
Full record on ClinicalTrials.gov
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