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

January 7, 2025 updated by: Xijing Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

340

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Adjuvant radiotherapy
receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy
Experimental: Neoadjuvant radiotherapy
receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery
Radiation: Neoadjuvant radiotherapy
The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-Free Survival (EFS)
Time Frame: 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.
From enrollment to 10 years later or death.
Invasive Disease-Free Survival (iDFS)
Time Frame: From enrollment to 10 years later or death.
From enrollment to 10 years later or death.
Overall Survival (OS)
Time Frame: From enrollment to 10 years later or death.
From enrollment to 10 years later or death.
Quality of life scores
Time Frame: From enrollment to 3 years after treatment completion.
From enrollment to 3 years after treatment completion.
ECOG performance status scores
Time Frame: From enrollment to 3 years after treatment completion.
From enrollment to 3 years after treatment completion.
Surgical incision healing scores
Time Frame: From enrollment to 1 years after treatment completion.
From enrollment to 1 years after treatment completion.
Adverse Events (AEs)
Time Frame: From enrollment to 3 years after treatment completion.
From enrollment to 3 years after treatment completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 31, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

January 3, 2025

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WZ-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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