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NCT Number: NCT06299930

Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neoadjuvant chemotherapy

Procedure

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

Other names: NACT

Adjuvant chemotherapy

Procedure

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

Other names: ACT

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2024
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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