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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05126667
• Other study ID #: UID 2762
• Status: Completed
• Start date: January 2000
• Est. completion date: November 2021

Study information

• Verified date: November 2021
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9710
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Breast-conserving surgery
Breast conserving surgery plus whole breast irradiation
• Mastectomy
Breast mastectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of ipsilateral breast tumor recurrence	Incidence of ipsilateral breast tumor recurrence in breast conserving surgery group compared to mastectomy group	10 years
Primary	Cumulative incidence of axillary lymph node recurrence	cumulative incidence of axillary lymph node recurrence in breast conserving surgery group compared to mastectomy group	10 years
Primary	Cumulative incidence of contralateral breast cancer	Cumulative incidence of contralateral breast cancer in breast conserving surgery group compared to mastectomy group	10 years
Primary	Rate of distant metastasis	Incidence of distant metastasis in breast conserving surgery group compared to mastectomy group	10 years
Primary	Cumulative incidence of breast cancer specific survival	Cumulative incidence of breast cancer specific survival in breast conserving surgery group compared to mastectomy group	10 years
Primary	Rate of overall survival	Incidence of survival in breast conserving surgery group compared to mastectomy group	10 years