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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06603805
Enrollment
974
Registered
2024-09-19
Start date
2008-01-01
Completion date
2024-01-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, breast-conserving surgery, radiotherapy, mastectomy

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.

Interventions

PROCEDUREMAST group
PROCEDUREbreast-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.

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026