What is elacestrant studying for advanced breast cancer?

Elacestrant is being studied in combination with everolimus to evaluate its effectiveness in treating advanced breast cancer that is ER-positive, HER2-negative, and has an ESR1 mutation. The trial aims to see if this combination can delay cancer progression in patients who have already received certain hormone and CDK4/6 inhibitor therapies. The study is sponsored by MedSIR and follows strict clinical procedures.

Who may be eligible for this advanced breast cancer clinical trial?

Adults aged 18 years or older with ER-positive, HER2-negative advanced breast cancer that has an ESR1 mutation may be eligible. Both women and men can participate, including pre- and postmenopausal women under specific hormone treatment conditions. Important factors include previous treatment history and organ function. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced breast cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses to and from the study site may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06382948

A Randomized Phase 3 Study of Elacestrant Plus Everolimus Versus Elacestrant Alone in Patients With ERHER2-, ESR1mut Advanced Breast Cancer Progressing After Endocrine Therapy and CDK46 Inhibitors

Led by MedSIR · Updated on 2026-04-03

240

Participants Needed

Research Sites

30 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a treatment for advanced breast cancer that is estrogen receptor-positive, HER2-negative, and has a specific ESR1 gene mutation. The study aims to find out how well a combination of elacestrant, a selective estrogen receptor degrader, and everolimus, a kinase inhibitor, works in patients whose cancer has progressed despite prior endocrine therapy and CDK46 inhibitor treatment. The study follows strict guidelines to ensure patient safety and compliance with international clinical standards. Participants will be randomly assigned to one of two groups. One group will receive elacestrant at 345 mg plus everolimus at 7.5 mg orally once daily, while the other group will receive elacestrant at the same dose plus a placebo instead of everolimus. Treatments will be given in 28-day cycles and continue until disease progression, unacceptable side effects, or other reasons for stopping the treatment occur. After stopping treatment, patients will be followed every three months for up to one year to monitor survival and any new cancer therapies. During the study, patients will undergo scans such as CT or MRI to confirm disease status, and tests to assess tumor markers and gene mutations. Researchers will monitor treatment effects, safety, and quality of life using questionnaires like the EQ-5D-5L and EORTC QLQ-C30 and QLQ-BR42. Side effects, blood counts, liver and kidney function, heart activity, and overall health status will be regularly checked. The main outcome is progression-free survival, measuring how long patients live without cancer worsening during treatment, with other outcomes including overall survival and treatment response. The total study duration for each participant averages about 12 months.

CONDITIONS

Brief Title

Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Able to understand the study and sign informed consent.
Female or male patients 18 years or older.
Premenopausal or perimenopausal women must receive LHRH analogues; postmenopausal women defined by age, menstrual history, or surgery.
Confirmed diagnosis of advanced or metastatic ER-positive, HER2-negative breast cancer.
ESR1 mutation confirmed by approved testing.
Disease progression after prior CDK4/6 inhibitor plus endocrine therapy.
Received 1 to 2 prior lines of endocrine therapy for advanced breast cancer.
No prior elacestrant, investigational SERDs, or PI3K/AKT/mTOR inhibitors including everolimus for advanced disease.
No prior chemotherapy for advanced disease.
Measurable or evaluable disease including certain bone lesions.
Willing to provide tumor tissue samples.
Fasting cholesterol and triglycerides within specified limits.
Adequate bone marrow, liver, kidney, and coagulation function.
Recovery from prior therapy side effects to mild or less.
Women of childbearing potential must have negative pregnancy test and use effective contraception.
Men with partners of childbearing potential must use effective contraception or abstain.
ECOG performance status 0-1.
Life expectancy of at least 12 weeks.

You will not qualify if you...

Unable to follow study procedures.
Visceral crisis or rapidly progressing symptomatic visceral disease.
Current participation in another therapeutic trial.
Recent cancer therapy within 14 days (except fulvestrant completed 28 days prior).
Active uncontrolled CNS metastases or leptomeningeal disease.
Intact uterus with history of certain endometrial conditions.
Other malignancies within 3 years except certain low-risk cancers.
Allergy to study drugs.
Conditions affecting pill swallowing or absorption.
Recent radiotherapy or major surgery.
Significant cardiovascular or cerebrovascular disease.
Uncontrolled arrhythmias or prolonged QT interval.
Severe lung diseases or prior pneumonectomy.
History or presence of interstitial lung disease or pneumonitis.
Recent or active coagulopathy except stable conditions.
Use of immunosuppressive or high-dose corticosteroids.
Inability to avoid certain medications or foods affecting drug metabolism.
Pregnant or breastfeeding women.
Active infections like HIV, HBV, or HCV unless resolved.
Substance abuse or uncontrolled psychiatric or medical conditions.

Research Team

Medsir

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