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Eliminating Breast Surgery for Breast Cancer Patients With Clinical Complete Response to Neoadjuvant Systemic Therapy

NCT06498154 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-12-19

No results posted yet for this study

Summary

Phase II multicenter prospective study on the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant radiotherapy and neoadjuvant chemotherapy.

Conditions

Interventions

RADIATION

Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy

Neoadjuvant radiotherapy: whole-breast irradiation ( 50 Gy in 25 fractions) plus a mandatory boost (14 Gy in seven fractions, which began on the day following completion of whole-breast irradiation) TCb (HP) \* : Triple negative patients will receive TCb regimens with or without immunotherapy and HER2 positive patients will receive TCb(HP) regimens.

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • The First Affiliated Hospital of Hainan Medical University

    collaborator OTHER_GOV

  • Shandong Cancer Hospital and Institute

    collaborator OTHER

  • First Affiliated Hospital of Kunming Medical University

    collaborator OTHER

  • Chongqing University Cancer Hospital

    collaborator OTHER

  • Tangshan People's Hospital

    collaborator OTHER

  • Taizhou Hospital

    collaborator OTHER

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • XUCHEN CAO, MD · TianJin Medical University Cancer Institute and Hospitall

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-07-25
Primary Completion
2026-12-30
Completion
2032-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06498154 on ClinicalTrials.gov