Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy

NCT ID: NCT06299930

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10328 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-22

Study Completion Date

2023-09-12

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Neoadjuvant chemotherapy (NACT) group

Patients who administered chemotherapy before surgery

Neoadjuvant chemotherapy

Intervention Type PROCEDURE

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

Adjuvant chemotherapy (ACT) group

Patients who administered chemotherapy after surgery

Adjuvant chemotherapy

Intervention Type PROCEDURE

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

Interventions

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Neoadjuvant chemotherapy

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

Intervention Type PROCEDURE

Adjuvant chemotherapy

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

Intervention Type PROCEDURE

Other Intervention Names

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NACT ACT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wonshik Han

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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LRR after NACT vs ACT

Identifier Type: -

Identifier Source: org_study_id

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