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Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06299930
Enrollment
10328
Registered
2024-03-08
Start date
2022-04-22
Completion date
2023-09-12
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

PROCEDURENeoadjuvant chemotherapy

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

PROCEDUREAdjuvant chemotherapy

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 100 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Locoregional recurrence-free survival (LRR)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 monthsTime interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of locoregional recurrence

Secondary

MeasureTime frameDescription
Distant metastasis-free survivalDefined 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 monthsTime interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of distant metastasis

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026