Clinical Trials Directory

Trials / Completed

CompletedNCT06603805

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

Status
Completed
Phase
Study type
Observational
Enrollment
974 (actual)
Sponsor
West China Hospital · Academic / Other
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREMAST group
PROCEDUREbreast-conserving surgery plus adjuvant radiotherapyPatients 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.

Timeline

Start date
2008-01-01
Primary completion
2019-12-31
Completion
2024-01-01
First posted
2024-09-19
Last updated
2024-09-19

Source: ClinicalTrials.gov record NCT06603805. Inclusion in this directory is not an endorsement.