Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy

March 1, 2024 updated by: Wonshik Han, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10328

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

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 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
Neoadjuvant chemotherapy (NACT) group
Patients who administered chemotherapy before surgery
Procedure: Neoadjuvant chemotherapy
Patients received neoadjuvant chemotherapy (either taxane-or anthracycline-based, or any cytotoxic chemotherapy) , followed by surgery and radiotherapy
Other Names:
  • NACT
Adjuvant chemotherapy (ACT) group
Patients who administered chemotherapy after surgery
Procedure: Adjuvant chemotherapy
Patients received adjuvant chemotherapy (either taxane-or anthracycline-based, or any cytotoxic chemotherapy) after surgery, followed by radiotherapy
Other Names:
  • ACT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Locoregional recurrence-free survival (LRR)
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distant metastasis-free survival
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

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)

April 22, 2022

Primary Completion (Actual)

August 16, 2023

Study Completion (Actual)

September 12, 2023

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRR after NACT vs ACT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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