NCT07085767 Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
| NCT ID | NCT07085767 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Olema Pharmaceuticals, Inc. |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-11-03 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,000 participants in total. It began in 2025-11-03 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Medical Director, MD
STUDY DIRECTOR
Olema Pharmaceuticals, Inc.
Frequently Asked Questions
Who can join the NCT07085767 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07085767 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,000 participants.
Is NCT07085767 currently recruiting?
Yes, NCT07085767 is actively recruiting participants. Contact the research team at OPERA-02@olema.com for enrollment information.
Where is the NCT07085767 trial being conducted?
This trial is being conducted at Hot Springs, United States, Beverly Hills, United States, La Jolla, United States, Los Alamitos, United States and 11 additional locations.
Who is sponsoring the NCT07085767 clinical trial?
NCT07085767 is sponsored by Olema Pharmaceuticals, Inc.. The principal investigator is Medical Director, MD at Olema Pharmaceuticals, Inc.. The trial plans to enroll 1,000 participants.
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