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Analysis of Breast-Conserving Surgery Plus Whole-Breast Irradiation Versus Mastectomy

A Propensity Score-Matched Analysis of Breast-Conserving Surgery Plus Whole-Breast Irradiation Versus Mastectomy in Breast Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05126667
Enrollment
9710
Registered
2021-11-19
Start date
2000-01-31
Completion date
2021-11-30
Last updated
2021-11-19

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

Conditions

Breast Cancer

Brief summary

This is a retrospective propensity score-matched analysis of a large institutional cohort of patients in order to compare long-term outcomes and clinicopathologic characteristics between patients treated with breast conserving surgery or mastectomy for breast cancer.

Detailed description

The aim of the study is to compare long-term outcomes and clinicopathologic characteristics between patients treated with breast conserving surgery + whole breast irradiation or mastectomy for breast cancer. Recent observations regarding long-term outcomes among patients with early-stage breast cancer who underwent breast-conserving surgery plus whole-breast irradiation or mastectomy are from a small number of registry-based studies. Therefore, these findings may overestimate differences in survival between the two groups, compared with randomized controlled trials conducted in the 1980s. This study performed a propensity score-matched analysis in a cohort of 9710 patients aged \<70 years who underwent breast conserving surgery + whole breast irradiation or mastectomy without external radiotherapy for a first primary breast cancer (pT1-2, N0-3a) at the European Institute of Oncology between 2000 and 2008. Patients were matched by propensity score.

Interventions

PROCEDUREBreast-conserving surgery

Breast conserving surgery plus whole breast irradiation

PROCEDUREMastectomy

Breast mastectomy

Sponsors

European Institute of Oncology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* First primary breast cancer * pT1-2 * pN0-3a * Surgery performed at European Institute of Oncology between 2000 and 2008

Exclusion criteria

* pT\>=3 * Neoadjuvant treatment * Presence of metastatic breast disease at the time of admission or within 3 months

Design outcomes

Primary

MeasureTime frameDescription
Cumulative incidence of ipsilateral breast tumor recurrence10 yearsIncidence of ipsilateral breast tumor recurrence in breast conserving surgery group compared to mastectomy group
Cumulative incidence of axillary lymph node recurrence10 yearscumulative incidence of axillary lymph node recurrence in breast conserving surgery group compared to mastectomy group
Cumulative incidence of contralateral breast cancer10 yearsCumulative incidence of contralateral breast cancer in breast conserving surgery group compared to mastectomy group
Rate of distant metastasis10 yearsIncidence of distant metastasis in breast conserving surgery group compared to mastectomy group
Cumulative incidence of breast cancer specific survival10 yearsCumulative incidence of breast cancer specific survival in breast conserving surgery group compared to mastectomy group
Rate of overall survival10 yearsIncidence of survival in breast conserving surgery group compared to mastectomy group

Outcome results

None listed

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