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RECRUITING
NCT07383818
PHASE2

Neoadjuvant Therapy Combined With Trastuzumab Rezetecan and Toripalimab for HR+/HER2-low Breast Cancer (NEOTORCH-BREAST 08)

Sponsor: First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

Summary

This study is a prospective, multi-cohort, multicenter, open-label exploratory clinical trial. The primary study objective is to evaluate the pathologic complete response (PCR) of treatment of HR+/HER2-low breast cancer with neoadjuvant therapy combined with Trastuzumab Rezetecan and Toripalimab , including the incidences and types of adverse events. The secondary endpoints include event-free survival (EFS), residual cancer burden (RCB), and objective response rate (ORR).

Official title: A Prospective, Multigroup, Multi-center, Open-label Clinical Study of Trastuzumab Rezetecan as Neoadjuvant Therapy Combined With Toripalimab in HR+/HER2-low Breast Cancer Patients (NEOTORCH-BREAST 08)

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

111

Start Date

2026-02-01

Completion Date

2031-02-01

Last Updated

2026-02-03

Healthy Volunteers

No

Interventions

DRUG

Neoadjuvant therapy combined with Trastuzumab Rezetecan and Toripalimab

Trastuzumab Rezetecan administered intravenously at a dose of 4.8mg/kg every 3 weeks for a total of 24 weeks with Toripalimab intravenous infusion of 240mg. During postoperative adjuvant therapy, Toripalimab used as before till a total of 1 year.

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.

Locations (5)

Harbin Medical University Cancer Hospital

Harbin, China

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Zhongshan Hospital, Fudan University

Shanghai, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Zhengzhou, China