Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy

NCT06299930 | Completed DMC

• 1 other identifier: LRR after NACT vs ACT
• Study Type: observational
• Target: 10,328
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Neoadjuvant chemotherapy (NACT) group

Patients who administered chemotherapy before surgery

Procedure: Neoadjuvant chemotherapy

Adjuvant chemotherapy (ACT) group

Patients who administered chemotherapy after surgery

Procedure: Adjuvant chemotherapy

Interventions

Neoadjuvant chemotherapy PROCEDURE

Patients received neoadjuvant chemotherapy (either taxane-or anthracycline-based, or any cytotoxic chemotherapy) , followed by surgery and radiotherapy

Also known as: NACT

Neoadjuvant chemotherapy (NACT) group

Adjuvant chemotherapy PROCEDURE

Patients received adjuvant chemotherapy (either taxane-or anthracycline-based, or any cytotoxic chemotherapy) after surgery, followed by radiotherapy

Also known as: ACT

Adjuvant chemotherapy (ACT) group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients who underwent breast-conserving surgery for breast cancer between January 1, 2004 and December 31, 2018 at the three leading hospitals in South Korea

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 8, 2024
• Study Start: April 22, 2022
• Primary Completion: August 16, 2023
• Study Completion: September 12, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

KR (1)