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

NCT06769919 | Not Yet Recruiting Phase 2

• 1 other identifier: WZ-1
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

radiotherapy; system therapy

Outcome Measures

Primary Outcomes (1)

• Residual Cancer Burden (RCB) 0/I

  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 Outcomes (7)

• 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.

Study Arms (2)

Adjuvant radiotherapy

NO INTERVENTION

receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy

Neoadjuvant radiotherapy

EXPERIMENTAL

receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery

Radiation: Neoadjuvant radiotherapy

Interventions

Neoadjuvant radiotherapy RADIATION

The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery

Neoadjuvant radiotherapy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Ju liang Zhang

CONTACT

029-84775271; vascularzhang@163.com

Mei ling Huang

CONTACT

029-84775271; huangmeiling@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 10, 2025
• Study Start: December 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031
• Last Updated: January 10, 2025

Record last verified: 2024-12

Locations

CN (1)