A Randomized Controlled Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined with Systemic Therapy for Early-stage Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neoadjuvant radiotherapy.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Radiation Neoadjuvant radiotherapy
The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery
Primary outcome measures
- Residual Cancer Burden (RCB) 0/I [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (7)
- Event-Free Survival (EFS) [Time frame: From enrollment to 10 years later or death.]
- Invasive Disease-Free Survival (iDFS) [Time frame: From enrollment to 10 years later or death.]
- Overall Survival (OS) [Time frame: From enrollment to 10 years later or death.]
- Quality of life scores [Time frame: From enrollment to 3 years after treatment completion.]
- ECOG performance status scores [Time frame: From enrollment to 3 years after treatment completion.]
- Surgical incision healing scores [Time frame: From enrollment to 1 years after treatment completion.]
- Adverse Events (AEs) [Time frame: From enrollment to 3 years after treatment completion.]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xijing hospital — Xi'an
Identifiers
NCT: NCT06769919 · WZ-1