A Randomized Controlled Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined with Systemic Therapy for Early-stage Breast Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 340
- Locations
- 1
- Primary Endpoint
- Residual Cancer Burden (RCB) 0/I
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
Adjuvant radiotherapy
receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy
Neoadjuvant radiotherapy
receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery
Intervention: Neoadjuvant radiotherapy (Radiation)
Outcomes
Primary Outcomes
Residual Cancer Burden (RCB) 0/I
Time Frame: 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 Outcomes
- Event-Free Survival (EFS)(From enrollment to 10 years later 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.)
- Surgical incision healing scores(From enrollment to 1 years after treatment completion.)
- Adverse Events (AEs)(From enrollment to 3 years after treatment completion.)