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RECRUITING
NCT05983107
PHASE2

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

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2023-07-20

Completion Date

2027-07-15

Last Updated

2023-08-09

Healthy Volunteers

No

Interventions

DRUG

Everolimus

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

DRUG

Chidamide

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

DRUG

Endocrine therapy

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

DRUG

Ovarian 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