Optimal Surgical Approach for Early-Stage Breast Cancer in Chinese Patients Aged ≤ 40 Years: a Cohort Study

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: MAST group; Procedure: breast-conserving surgery plus adjuvant radiotherapy

• Registration Number: NCT06603805
• Lead Sponsor: West China Hospital

Brief Summary

The optimal surgical treatment option (BCS+RT versus MAST) for young patients with early-stage breast cancer remains debated. The present study aims to explore trends in surgical management and compare survival outcomes between BCS+RT and MAST in young patients with early-stage breast cancer, ultimately providing optimal treatment strategies for Asian populations.

Detailed Description

This study is a unique addition to the current research on young women with early-stage breast cancer, aiming to compare the survival outcomes between BCS+RT and MAST, providing valuable insights into their effectiveness for this group of patients. This study enrolled patients at West China Hospital, Sichuan University. Kaplan-Meier analyses with the log-rank test were applied to compare the locoregional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), breast cancer-specific survival (BCSS), and overall survival (OS). Cox multivariate hazard regression was employed to assess hazard ratios (HRs) between the two groups for survival outcomes.

Study Timeline

• Study Start: 2008-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2024-01-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 974

Inclusion Criteria

• Patients aged 18-40 years.
• Pathological diagnosis of invasive breast cancer.
• Undergoing Breast-Conserving Surgery (BCS) with Radiotherapy (RT) or Mastectomy (MAST).
• Availability of detailed clinical information, including:

Tumor (T) stage. Node (N) stage. Clinical stage. Hormone receptor status. Endocrine therapy details. Targeted therapy details.

Exclusion Criteria

• Male patients.
• Patients with distant metastatic disease.
• Patients with bilateral breast cancer.
• Patients not undergoing surgery.
• Follow-up time of less than 1 month.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MAST group	MAST group	patients 1) aged between 18-40 years; 2) with a primary pathological diagnosis of invasive breast cancer; 3) receiving MAST; 4) having detailed information on T stage, N stage, clinical stage, hormone receptor status, endocrine therapy, and targeted therapy.
BCS+RT group	breast-conserving surgery plus adjuvant radiotherapy	Patients 1) aged between 18-40 years; 2) with a primary pathological diagnosis of invasive breast cancer; 3) receiving BCS+ RT; 4) having detailed information on T stage, N stage, clinical stage, hormone receptor status, endocrine therapy, and targeted therapy.

Primary Outcome Measures

Name	Time	Method
Breast cancer-specific survival (BCSS)	Jan 1, 2008 to 31 Dec, 2019
LRFS (Locoregional Recurrence-Free Survival)	Jan 1, 2008 to 31 Dec, 2019
DMFS (Distant Metastasis-Free Survival)	Jan 1, 2008 to 31 Dec, 2019
OS (Overall Survival)	Jan 1, 2008 to 31 Dec, 2019