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

NCT07383818 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2026-02-03

No results posted yet for this study

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).

Conditions

  • HR Positive/HER2 Low Breast Cancer

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.

Sponsors & Collaborators

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2028-02-01
Completion
2031-02-01

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 NCT07383818 on ClinicalTrials.gov