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

NCT ID: NCT06603805

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 974 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-01
• Study Completion Date: 2024-01-01

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

MAST group

Intervention Type: PROCEDURE

BCS+RT group

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.

breast-conserving surgery plus adjuvant radiotherapy

Intervention Type: PROCEDURE

Patients with early-stage (stage I, stage II, T≤2), and having the willingness to receive BCS were treated with BCS. All patients with BCS received post-surgery radiotherapy. Radiotherapy was administrated with a prescribed dose of 40 Gy in 15 fractions with photons and a boost of 10-16 Gy in 5-8 fractions with electrons to the ipsilateral breast. If axillary lymph nodes were involved, a conventional fraction was delivered with a prescribed dose of 50 Gy in 25 fractions to the ipsilateral breast and draining lymph node regions.

Interventions

MAST group

Intervention Type: PROCEDURE

breast-conserving surgery plus adjuvant radiotherapy

Patients with early-stage (stage I, stage II, T≤2), and having the willingness to receive BCS were treated with BCS. All patients with BCS received post-surgery radiotherapy. Radiotherapy was administrated with a prescribed dose of 40 Gy in 15 fractions with photons and a boost of 10-16 Gy in 5-8 fractions with electrons to the ipsilateral breast. If axillary lymph nodes were involved, a conventional fraction was delivered with a prescribed dose of 50 Gy in 25 fractions to the ipsilateral breast and draining lymph node regions.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lei Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2020427

Identifier Type: -

Identifier Source: org_study_id