Optimal Surgical Approach for Early-Stage Breast Cancer in Chinese Patients Aged ≤ 40 Years: a Cohort Study
September 18, 2024 updated by: Lei Liu, West China Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
974
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The patient data were extracted from the West China Hospital database at Sichuan University.
Records between 1 January 2008 and 31 December 2019 were included.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Breast cancer-specific survival (BCSS)
Time Frame: Jan 1, 2008 to 31 Dec, 2019
|
Jan 1, 2008 to 31 Dec, 2019
|
|
LRFS (Locoregional Recurrence-Free Survival)
Time Frame: Jan 1, 2008 to 31 Dec, 2019
|
Jan 1, 2008 to 31 Dec, 2019
|
|
DMFS (Distant Metastasis-Free Survival)
Time Frame: Jan 1, 2008 to 31 Dec, 2019
|
Jan 1, 2008 to 31 Dec, 2019
|
|
OS (Overall Survival)
Time Frame: Jan 1, 2008 to 31 Dec, 2019
|
Jan 1, 2008 to 31 Dec, 2019
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2008
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
January 1, 2024
Study Registration Dates
First Submitted
September 10, 2024
First Submitted That Met QC Criteria
September 18, 2024
First Posted (Estimated)
September 19, 2024
Study Record Updates
Last Update Posted (Estimated)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 18, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020427
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.