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

Targeted Therapy Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

This study is an open, multi center, prospective cohort, and Phase II exploratory research. According to the PIK3CA gene mutation status of patients, the study is divided into two cohorts. The PIK3CA Mutant uses everolimus combined with endocrine therapy as the cohort A, and the PIK3CA wild type uses chidamide combined with endocrine therapy as the cohort B, until the disease progresses or the toxicity is intolerable. According to the judgment of the researchers, whether to enter the second stage of cross design, Queue A was cross administered with chidamide in combination with endocrine therapy. Cohort B cross used everolimus combined with endocrine until the disease progressed or the toxicity was intolerable. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05983107
Study type Interventional
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact
Status Recruiting
Phase Phase 2
Start date July 20, 2023
Completion date July 15, 2027
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