RecruitingPhase 2NCT05949541

Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer

Study of Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- (Open, Randomized, Phase II )


Sponsor

Fudan University

Enrollment

265 participants

Start Date

Jul 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized, controlled, open-label, phase II study to explore the efficacy and safety of Everolimus in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF1 subtype of advanced breast cancer. The study was used to explore the efficacy of Everolimus in combination with standard endocrine therapy.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called everolimus to standard hormone therapy helps treat a specific subtype of advanced breast cancer (called HR+/HER2- SNF1 subtype). This is for patients whose cancer has spread or cannot be removed with surgery and who have not yet received treatment for advanced disease. **You may be eligible if...** - You are between 18 and 75 years old - You have hormone receptor-positive (HR+), HER2-negative breast cancer that is locally advanced or metastatic - Your cancer has been confirmed as the SNF1 subtype by a special test - You have not previously received chemotherapy or targeted therapy for advanced or metastatic disease - You have at least one measurable tumor that has not been previously treated with radiation - Your organ function (blood counts, liver, kidneys) meets required levels **You may NOT be eligible if...** - Your cancer has spread to your brain in an uncontrolled way - You have had a serious heart condition (heart failure, heart attack) in the last 6 months - You received cancer treatment within 4 weeks before starting this study - You are pregnant or breastfeeding - You have had another cancer in the past 3 years (with some exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEverolimus 10 mg

Everolimus is a kind of mTOR inhibitor which has been approved to use in several kinds of cancers, especially in metastatic breast cancer.

DRUGCDK4/6 Inhibitor SHR6390

Dalpiciclib (SHR6390) is a kind of CDK4/6 inhibitor that has demonstrated tolerability and preliminary clinical activity in patients with heavily pretreated hormone receptor-positive, HER2-negative advanced breast cancer.

DRUGAromatase inhibitor and Fulvestrant combined with CDK4/6 inhibitors

Endocrine therapy combined with CDK4/6 inhibitors is the standard first-line therapy for advanced luminal breast cancer. Investigators choose endocrine therapy including Letrozole, Anastrozole, Exemestane, and Fulvestrant. Postmenopausal participants should use Goserelin.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT05949541


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