RecruitingPhase 2NCT05983107

Chidamide/Everolimus for PIK3CA Wild-type/Mutant HR+/HER2- Advanced Breast Cancer

A Prospective Cohort, Open, Phase II Clinical Study of Chidamide/Everolimus Combined With Endocrine Therapy for PIK3CA Wild-type/Mutant Hormone Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

102 participants

Start Date

Jul 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

To explore the efficacy and safety of chidamide combined with endocrine in phosphoinositide-3-kinase,catalytic,alpha gene(PI3KCA) wild type hormone receptor positive(HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer patients and to explore the efficacy and safety of Everolimus combined with endocrine therapy in patients with PI3KCA Mutant HR+/HER2- advanced breast cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — chidamide (a type of targeted cancer drug) and everolimus (an immune-modulating drug) — for women with hormone receptor-positive, HER2-negative advanced breast cancer whose cancer progressed after treatment with CDK4/6 inhibitors. The study has two groups based on whether patients have a specific genetic mutation (PIK3CA). **You may be eligible if:** - You are a woman aged 18–75 with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer - Your cancer progressed after CDK4/6 inhibitor therapy - You have received no more than 2 prior lines of chemotherapy - You have at least one measurable tumor on imaging - Your general health allows treatment (ECOG score 0–2) **You may NOT be eligible if:** - You have received prior treatment with drugs similar to chidamide or everolimus - You have uncontrolled infections, severe organ dysfunction, or active autoimmune disease - You are pregnant or breastfeeding 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

Everolimus combined with endocrine therapy(tamoxifen, letrozole, anastrozole, exemestane, fulvestrant, etc.Goserelin, leuprolide, premenopausal patients only, selected at the discretion of the investigator)

DRUGChidamide

Chidamide combined with endocrine therapy(tamoxifen, letrozole, anastrozole, exemestane, fulvestrant, etc.goserelin, leuprolide, premenopausal patients only, selected at the discretion of the investigator)

DRUGEndocrine therapy

Tamoxifen, letrozole, anastrozole, exemestane, fulvestrant, etc, selected at the discretion of the investigator.

DRUGOvarian function suppression(OFS)

Goserelin, leuprolide, premenopausal patients only, selected at the discretion of the investigator.


Locations(1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

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NCT05983107


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