Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer : a Randomized, Open-label, Parallel-controlled, Multi-center Phase III Study (NEOTORCH-BREAST04)

PHASE3RecruitingINTERVENTIONAL
Enrollment

194

Participants

Timeline

Start Date

March 24, 2025

Primary Completion Date

March 23, 2027

Study Completion Date

March 23, 2030

Conditions
HR+/HER2- Breast Cancer
Interventions
DRUG

Neoadjuvant Chemotherapy in Combination with Toripalimab

Epirubicin (or Liposomal Doxorubicin)+Cyclophosphamide, intravenous infusion of 100 mg/m2. Epirubicin (or 35 mg/m2 liposomal doxorubicin)+600 mg/m2 cyclophosphamide, starting from the first day of the week, for a total of 12 weeks. Paclitaxel, administered intravenously at a dose of 260 mg/m2 every 3 weeks for a total of 12 weeks. During neoadjuvant chemotherapy and postoperative adjuvant therapy, use of Toripalimab: intravenous infusion of 240 mg, once every 3 weeks, combined with preoperative neoadjuvant and postoperative adjuvant therapy for a total of 1 year.

DRUG

Neoadjuvant Chemotherapy

Epirubicin (or Liposomal Doxorubicin)+Cyclophosphamide, intravenous infusion of 100 mg/m2. Epirubicin (or 35 mg/m2 liposomal doxorubicin)+600 mg/m2 cyclophosphamide, starting from the first day of the week, for a total of 12 weeks. Paclitaxel, administered intravenously at a dose of 260 mg/m2 every 3 weeks for a total of 12 weeks.

Trial Locations (13)

Unknown

NOT_YET_RECRUITING

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou

RECRUITING

The First Affiliated Hospital of Zhejiang University, Hangzhou

RECRUITING

Zhejiang Cancer Hospital, Hangzhou

NOT_YET_RECRUITING

Harbin Medical University Cancer Hospital, Harbin

NOT_YET_RECRUITING

The First Affiliated Hospital of Anhui Medical University, Hefei

NOT_YET_RECRUITING

Jinhua Municipal Central Hospital, Jinhua

NOT_YET_RECRUITING

Nanchang People's Hospital, Nanchang

NOT_YET_RECRUITING

Nantong First People's Hospital, Nantong

NOT_YET_RECRUITING

Zhongshan Hospitall, Fudan University, Shanghai

NOT_YET_RECRUITING

Xinjiang Medical University Affiliated Cancer Hospital, Ürümqi

NOT_YET_RECRUITING

Shaanxi Provincial Cancer Hospital, Xi'an

NOT_YET_RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an

NOT_YET_RECRUITING

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

All Listed Sponsors
lead

First Affiliated Hospital of Zhejiang University

OTHER