A Randomized Controlled Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined with Systemic Therapy for Early-stage Breast Cancer

Phase 2

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06769919
• Lead Sponsor: Xijing Hospital

Brief Summary

A total of 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity were enrolled and divided into two groups. The control group received neoadjuvant systemic therapy followed by surgery and adjuvant radiotherapy. The experimental group received neoadjuvant systemic therapy and neoadjuvant radiotherapy followed by surgery. The treatment response of breast cancer, patient survival time, and treatment safety were subsequently evaluated.

Detailed Description

This study is a randomized, controlled, open-label clinical trial, planned to enroll 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity. Participants will be divided into two groups. The control group will receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy. The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery.

After providing full informed consent and signing the informed consent form, eligible participants will enter the trial period upon screening. Within 72 hours of enrollment confirmation, participants will begin neoadjuvant therapy. Patients in the control group will receive a neoadjuvant systemic therapy regimen selected by their physician, followed by surgery and adjuvant radiotherapy. Patients in the experimental group will receive both neoadjuvant systemic therapy and neoadjuvant radiotherapy. The radiotherapy regions will include the whole breast, supraclavicular and infraclavicular areas, and internal mammary regions, with a dose of 50 Gy over 25 fractions, plus a tumor bed boost of 10-16 Gy over 4-8 fractions.

Primary Endpoint:

Residual Cancer Burden (RCB) 0/I.

Secondary Endpoints:

Event-Free Survival (EFS) Invasive Disease-Free Survival (iDFS) Overall Survival (OS) Quality of life scores ECOG performance status scores Surgical incision healing scores Adverse Events (AEs)

Inclusion Criteria:

Participants must meet all of the following criteria to be eligible for the trial:

1. Female patients aged ≥18 years and ≤65 years with newly diagnosed breast cancer;

2. Early-stage or locally advanced invasive breast cancer confirmed by histopathology according to the latest ASCO/CAP guidelines, meeting the following conditions:Axillary lymph node biopsy-positive;ECOG performance status score of 0-1;

3. Presence of at least one measurable lesion based on RECIST 1.1 criteria.

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-31
• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 340

Inclusion Criteria

• Female patients aged ≥18 years and ≤65 years；
• newly diagnosed breast cancer;
• Axillary lymph node biopsy-positive;
• ECOG performance status score of 0-1;

Exclusion Criteria

• metastatic breast cancer or bilateral breast cancer;
• inflammatory breast cancer;
• Pregnancy and Lactation;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Residual Cancer Burden (RCB) 0/I	From enrollment to the end of treatment at 8 weeks	Residual Cancer Burden (RCB) is a standardized method used to quantify the amount of residual disease in breast cancer patients after neoadjuvant therapy (treatment given before surgery). It is calculated based on the size of the primary tumor, the cellularity of the tumor bed, and the extent of lymph node involvement. RCB is divided into four categories: RCB-0: Pathologic complete response (pCR), meaning no residual invasive cancer is found in the breast or lymph nodes.; RCB-I: Minimal residual disease, indicating a very small amount of cancer remains after treatment.; RCB-II: Moderate residual disease. RCB-III: Extensive residual disease. RCB-0 and RCB-I are often associated with better prognoses and higher survival rates compared to RCB-II and RCB-III

Secondary Outcome Measures

Name	Time	Method
Surgical incision healing scores	From enrollment to 1 years after treatment completion.
Adverse Events (AEs)	From enrollment to 3 years after treatment completion.
Event-Free Survival (EFS)	From enrollment to 10 years later or death.	Event-Free Survival (EFS) is defined as the time from randomization to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death.
Invasive Disease-Free Survival (iDFS)	From enrollment to 10 years later or death.
Overall Survival (OS)	From enrollment to 10 years later or death.
Quality of life scores	From enrollment to 3 years after treatment completion.
ECOG performance status scores	From enrollment to 3 years after treatment completion.

Trial Locations

Locations (1)

Xijing hospital; 🇨🇳 Xi'an, Shaanxi, China