NCT05253066

Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer

An Open, Multicenter, Randomized Controlled Clinical Study of Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Shengjing Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open, multicenter, randomized controlled clinical study aimed to explore the efficacy and safety of chidamide combined with exemestane (+/- goserelin) versus chemotherapy in the neoadjuvant treatment of stage II-III HR +/HER2- breast cancer patients with poor response to previous chemotherapy.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Chidamide combined with exemestane (+/- goserelin)	Chidamide combined with exemestane (+/- goserelin)
DRUG	Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)	Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)

Timeline

• Start date: 2022-02-25
• Primary completion: 2022-07-31
• Completion: 2025-01-31
• First posted: 2022-02-23
• Last updated: 2022-02-23