Study on Elacestrant Combination Therapy for Patients with Metastatic Breast Cancer
Sponsor: Stemline Therapeutics, Inc.
ClinicalTrials ID:NCT05563220
This clinical trial is testing the safety and effectiveness of the drug elacestrant when combined with other medications in treating patients with advanced or metastatic breast cancer. The study is divided into two phases to determine the best dose and evaluate the treatment's impact.
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Program Overview
This study is being conducted at multiple centers and is divided into two phases. Phase 1b aims to find the best dose of elacestrant when used with other drugs like alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib. Phase 2 will assess how well these combinations work and how safe they are for patients with advanced or metastatic breast cancer that is ER+ and HER2-.
Description
The trial is structured in two parts: Phase 1b and Phase 2.
In Phase 1b, researchers will determine the best dose of elacestrant when combined with other drugs. This phase will involve small groups of patients to ensure the dose is safe and causes minimal side effects.
In Phase 2, the study will evaluate how effective and safe these drug combinations are in treating patients with ER+/HER2- advanced or metastatic breast cancer.
The study includes different treatment groups:
- Arm A: Elacestrant with alpelisib for 50 patients.
- Arm B: Elacestrant with everolimus for 50 patients.
- Arm C: Elacestrant with either abemaciclib or ribociclib for 60 patients.
- Arm D: Elacestrant with either palbociclib, abemaciclib, or ribociclib for 90 patients.
- Arm E: Elacestrant with capivasertib for 60 patients.
Phase 1b will include 90 patients, while Phase 2 will involve 310 patients across all treatment groups.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent before participating in the study.
- Men or women aged 18 years or older.
- Women can be of any menopausal status, with specific criteria for postmenopausal status.
- Premenopausal and perimenopausal women and men must be receiving a hormone treatment called LHRH agonist.
- Confirmed diagnosis of ER+, HER2- breast cancer.
- At least one measurable tumor that has not been treated with radiation.
- Good overall health with an ECOG performance status of 0 or 1.
- Adequate blood cell counts and organ function based on specific lab tests.
- Women of childbearing potential must use effective contraception during the study and for 120 days after the last treatment.
- Men must agree to use contraception and not donate sperm during the study and for 120 days after the last treatment.
Exclusion Criteria
- Active or newly diagnosed cancer spread to the brain or spinal cord.
- Advanced cancer spread to organs that could cause life-threatening complications.
- Previous treatment with chemotherapy or elacestrant for advanced cancer.
- Known genetic mutation (BRCA) without prior treatment with a specific inhibitor.
- Previous treatment with certain estrogen receptor-targeting drugs in the metastatic setting.
- Other active cancers or history of invasive cancer within the last 3 years, except for certain skin or bladder cancers.
- Uncontrolled infections or significant medical conditions.
- Pregnant or breastfeeding women.
- Inability to take oral medications or conditions affecting drug absorption.
- Known intolerance to elacestrant or its ingredients.
- Recent use of certain medications or herbal supplements.
- Ongoing alcohol or drug abuse.
- Severe medical or psychiatric conditions that could interfere with the study.
Additional criteria apply for specific drug combinations, such as having a PIK3CA mutation for the alpelisib combination or not having prior treatment with certain drugs for other combinations.
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