Skip to main content
OpenTrials
Completed

NCT Number: NCT05126667

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Breast-conserving surgery

Procedure

Breast conserving surgery plus whole breast irradiation

mastectomy

Procedure

Breast mastectomy

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Rate of distant metastasis

    Time frame: 10 years

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

  5. 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

  6. Rate of overall survival

    Time frame: 10 years

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

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2021
Registry last updated
Nov 19, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.