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

NCT06603805 | Completed DMC

• 1 other identifier: 2020427
• Study Type: observational
• Target: 974
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

breast cancer; breast-conserving surgery; radiotherapy; mastectomy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Procedure: MAST group

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.

Procedure: breast-conserving surgery plus adjuvant radiotherapy

Interventions

MAST group PROCEDURE

MAST group

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.

BCS+RT group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Male patients.
• Patients with distant metastatic disease.
• Patients with bilateral breast cancer.
• Patients not undergoing surgery.
• Follow-up time of less than 1 month.

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental; Radiotherapy, Adjuvant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative; Combined Modality Therapy; Therapeutics; Radiotherapy

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2008
• Primary Completion: December 31, 2019
• Study Completion: January 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09