Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Neoadjuvant chemotherapy; Procedure: Adjuvant chemotherapy

• Registration Number: NCT06299930
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Neoadjuvant chemotherapy (NACT) for early-stage breast cancer is associated with an increased risk of locoregional recurrence (LRR). However, few studies have conducted subgroup analyses of patients with various molecular subtypes, which are one of the determinant factors for treatments. The aim of the study is to investigate whether the risk of LRR after NACT varies across tumor subtypes. The investigators retrospectively reviewed the medical records of female breast cancer patients who underwent breast-conserving surgery at three institutions between January 1, 2004, and Dec 31, 2018.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-22
• Primary Completion: 2023-08-16
• Study Completion: 2023-09-12
• Study First Submitted: 2024-02-14
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-01
• Last Update Submitted: 2024-03-01
• Study First Posted: 2024-03-08
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10328

Inclusion Criteria

• Patients who underwent breast-conserving surgery for invasive breast cancer between 2004 and 2018

Exclusion Criteria

• Total mastectomy
• No pre- or postoperative chemotherapy
• No radiation therapy
• Bilateral breast cancer
• Male breast cancer patients
• Secondary breast cancer
• Metachronous or synchronous cancers

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neoadjuvant chemotherapy (NACT) group	Neoadjuvant chemotherapy	Patients who administered chemotherapy before surgery
Adjuvant chemotherapy (ACT) group	Adjuvant chemotherapy	Patients who administered chemotherapy after surgery

Primary Outcome Measures

Name	Time	Method
Locoregional recurrence-free survival (LRR)	Defined as the time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of LRR, assessed up to 120 months	Time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of locoregional recurrence

Secondary Outcome Measures

Name	Time	Method
Distant metastasis-free survival	Defined as the time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of distant metastasis, assessed up to 120 months	Time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of distant metastasis

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of