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Clinical Trials/NCT05126667
NCT05126667CompletedNot Applicable

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

European Institute of Oncology0 sites9,710 target enrollmentStarted: January 2000Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
9,710
Primary Endpoint
Cumulative incidence of ipsilateral breast tumor recurrence

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •First primary breast cancer
  • •Surgery performed at European Institute of Oncology between 2000 and 2008

Exclusion Criteria

  • •Neoadjuvant treatment
  • •Presence of metastatic breast disease at the time of admission or within 3 months

Outcomes

Primary Outcomes

Cumulative incidence of ipsilateral breast tumor recurrence

Time Frame: 10 years

Incidence of ipsilateral breast tumor recurrence in breast conserving surgery group compared to mastectomy group

Rate of distant metastasis

Time Frame: 10 years

Incidence of distant metastasis in breast conserving surgery group compared to mastectomy group

Cumulative incidence of axillary lymph node recurrence

Time Frame: 10 years

cumulative incidence of axillary lymph node recurrence in breast conserving surgery group compared to mastectomy group

Rate of overall survival

Time Frame: 10 years

Incidence of survival in breast conserving surgery group compared to mastectomy group

Cumulative incidence of contralateral breast cancer

Time Frame: 10 years

Cumulative incidence of contralateral breast cancer in breast conserving surgery group compared to mastectomy group

Cumulative incidence of breast cancer specific survival

Time Frame: 10 years

Cumulative incidence of breast cancer specific survival in breast conserving surgery group compared to mastectomy group

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
European Institute of Oncology
Sponsor Class
Other
Responsible Party
Sponsor

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