Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
Purpose
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.
Conditions
- Breast Cancer
- Locally Advanced Breast Cancer
- Metastatic Breast Cancer
- ER Positive Breast Cancer
- HER2 Negative Breast Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Palazestrant |
Participants will receive palazestrant, ribociclib and letrozole-matching placebo |
|
|
Active Comparator Letrozole |
Participants will receive letrozole, ribociclib and palazestrant-matching placebo |
|
Recruiting Locations
Clinical Trial Site
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Olema Pharmaceuticals, Inc.
Detailed Description
This is an international, multicenter, randomized, double-blind, active-controlled, phase 3 clinical trial. The purpose of this trial is to compare the efficacy and safety of palazestrant in combination with ribociclib +letrozole -matching placebo (Arm A: investigational arm) with letrozole in combination with ribociclib + palazestrant-matching placebo (Arm B: control arm). This trial is seeking adult participants with ER+, HER2- advanced breast cancer who have not received prior systemic anti-cancer treatment for advanced disease. Approximately 1,000 participants will be randomized in a 1:1 ratio to one of the two study arms.