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Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOTORCH-BREAST01)

NCT06611813 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-12

No results posted yet for this study

Summary

This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the pathologic complete response（PCR）and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer with Toripalimab combined with neoadjuvant chemotherapy and sequential Toripalimab monoclonal antibody, including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response Rate(ORR)

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

HR+ HER2 breast cancer

During neoadjuvant chemotherapy and postoperative adjuvant therapy, use of Toripalimab: intravenous infusion of 240 mg, once every 3 weeks, combined with preoperative neoadjuvant therapy and postoperative adjuvant therapy for a total of 1 year.

Sponsors & Collaborators

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Guansheng Sheng · Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-11
Primary Completion
2026-06-30
Completion
2029-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06611813 on ClinicalTrials.gov