NCT05983107

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HR+/HER2- Advanced Breast Cancer
• Targeted Therapy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-20
• Primary completion: 2026-07-15
• Completion: 2027-07-15
• First posted: 2023-08-09
• Last updated: 2023-08-09

Locations

1 site across 1 country: China