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

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MAST group

Procedure

breast-conserving surgery plus adjuvant radiotherapy

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.

Primary outcomes

Breast cancer-specific survival (BCSS)

Time frame: Jan 1, 2008 to 31 Dec, 2019
LRFS (Locoregional Recurrence-Free Survival)

Time frame: Jan 1, 2008 to 31 Dec, 2019
DMFS (Distant Metastasis-Free Survival)

Time frame: Jan 1, 2008 to 31 Dec, 2019
OS (Overall Survival)

Time frame: Jan 1, 2008 to 31 Dec, 2019

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2019
Study completion: 2024
First posted: Sep 19, 2024
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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