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RECRUITING
NCT07376538
PHASE2

Response-Based Local Therapy for Regionally Advanced Breast Cancer

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

Summary

The goal of this interventional clinical trial is to evaluate if an individualized treatment strategy (involving radiation boost, surgery, and systemic consolidation) can improve progression-free survival in patients with breast cancer presenting with positive ipsilateral supraclavicular (ISLN) and/or internal mammary lymph nodes (IMLN). The main questions it aims to answer are: Is individualized hypofractionated radiotherapy with a local boost safe and effective when adjusted by the response to neoadjuvant treatment? Does local surgery provide benefit for patients who have high residual tumor burden in these lymph nodes after neoadjuvant treatment? How effective is intensified systemic therapy when tailored to the patient's molecular subtype?

Official title: A Prospective Phase II Clinical Study of Response-Based Local Therapy After Systemic Therapy in Regionally Advanced Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

157

Start Date

2026-02

Completion Date

2033-02

Last Updated

2026-02-11

Healthy Volunteers

No

Conditions

Interventions

RADIATION

Response-adapted comprehensive treatment strategy

Participants will receive a response-adapted comprehensive treatment strategy following neoadjuvant systemic therapy (NST). The strategy includes: Surgery: Patients with residual ISLN/IMLN ≥ 0.5 cm after NST are assigned (1:1) to receive either regional lymph node dissection or no dissection, in addition to standard breast and axillary surgery. Radiotherapy: Patients receive individualized, dose-adaptive hypofractionated or conventional fractionation radiotherapy guided by the response of the breast and regional nodes to NST. Systemic Therapy: Intensified consolidation systemic therapy is administered based on NST efficacy.

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China