Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy

Breast Cancer Clinical Trial

Official title:

Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy Based on Tumor Subtypes in Patients With Early-stage Breast Cancer: A Multi-institutional Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06299930
• Other study ID #: LRR after NACT vs ACT
• Status: Completed
• Start date: April 22, 2022
• Est. completion date: September 12, 2023

Study information

• Verified date: March 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10328
• Est. completion date: September 12, 2023
• Est. primary completion date: August 16, 2023
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Recurrence

Intervention

Procedure:
• Neoadjuvant chemotherapy
Patients received neoadjuvant chemotherapy (either taxane-or anthracycline-based, or any cytotoxic chemotherapy) , followed by surgery and radiotherapy
• Adjuvant chemotherapy
Patients received adjuvant chemotherapy (either taxane-or anthracycline-based, or any cytotoxic chemotherapy) after surgery, followed by radiotherapy

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locoregional recurrence-free survival (LRR)	Time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of locoregional recurrence	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
Secondary	Distant metastasis-free survival	Time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of distant metastasis	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