Response-Based Local Therapy for Regionally Advanced Breast Cancer

NCT07376538 | Recruiting Phase 2

• 1 other identifier: NCC5176
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Breast Cancer

Keywords

Regionally Advanced Breast Cancer; Hypofractionated Radiotherapy; Systemic Consolidation Therapy; Breast Surgery; Regional Lymph Node Dissection

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Up to 5 years

Secondary Outcomes (4)

• Overall Survival (OS)

  Up to 5 years

• Cumulative Incidence of Locoregional Recurrence

  Up to 5 years

• Cumulative Incidence of Distant Metastasis

  Up to 5 years

• Incidence of Treatment-Related Toxicities

  Up to 5 years

Study Arms (1)

Response-Adapted comprehensive treatment strategy

EXPERIMENTAL

Radiation: Response-adapted comprehensive treatment strategy

Interventions

Response-adapted comprehensive treatment strategy RADIATION

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.

Response-Adapted comprehensive treatment strategy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18 to 75 years.
• ECOG performance status ≤ 2.
• Histologically confirmed invasive breast cancer.
• Newly diagnosed breast cancer with pathologically confirmed positive ipsilateral supraclavicular lymph nodes (ISLN) and/or internal mammary lymph nodes (IMLN); for patients in whom IMLN biopsy is not feasible, clinically positive IMLN based on investigator assessment and imaging findings is acceptable.
• Planned to receive neoadjuvant systemic therapy followed by breast-conserving surgery or mastectomy and axillary lymph node dissection, with or without supraclavicular and/or internal mammary lymph node dissection.
• Adequate baseline organ function, defined as: absolute neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; hemoglobin ≥ 9 g/dL (90 g/L); serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min; total bilirubin ≤ 1.5 × ULN; AST and/or ALT ≤ 2.5 × ULN; INR ≤ 1.5 and PT/APTT ≤ 1.5 × ULN.
• Able and willing to comply with study procedures and scheduled follow-up.
• Written informed consent obtained prior to any study-related procedures.

You may not qualify if:

• Evidence of distant metastatic disease.
• Presence of severe or uncontrolled concomitant diseases, including severe cardiac dysfunction; myocardial infarction, uncontrolled arrhythmia, or unstable angina within 3 months prior to enrollment; clinically significant pericardial disease; or severe pulmonary disease.
• Prior radiotherapy to the chest wall or supraclavicular region.
• Pregnancy, lactation, or any condition considered by the investigator to contraindicate radiotherapy.
• History of or concurrent second primary malignancy, except for non-melanoma skin cancer, papillary or follicular thyroid carcinoma, carcinoma in situ of the cervix, contralateral non-invasive breast cancer, or other malignancies treated with curative intent with no evidence of disease for more than 3 years.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 29, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2033
• Last Updated: February 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)