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

Sponsor
European Institute of Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT05126667
Collaborator
(none)
9,710
262

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Breast-conserving surgery
  • Procedure: Mastectomy

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
Actual Enrollment :
9710 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Propensity Score-Matched Analysis of Breast-Conserving Surgery Plus Whole-Breast Irradiation Versus Mastectomy in Breast Cancer
Actual Study Start Date :
Jan 1, 2000
Actual Primary Completion Date :
Nov 1, 2021
Actual Study Completion Date :
Nov 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Breast-conserving surgery

Patients who underwent breast-conserving surgery plus whole-breast irradiation

Procedure: Breast-conserving surgery
Breast conserving surgery plus whole breast irradiation

Mastectomy

Patients who underwent mastectomy

Procedure: Mastectomy
Breast mastectomy

Outcome Measures

Primary Outcome Measures

  1. Cumulative incidence of ipsilateral breast tumor recurrence [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 [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 [10 years]

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

  4. Rate of distant metastasis [10 years]

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

  5. Cumulative incidence of breast cancer specific survival [10 years]

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

  6. Rate of overall survival [10 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • European Institute of Oncology

Investigators

  • Principal Investigator: Francesca Magnoni, MD, European Institute of Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
European Institute of Oncology
ClinicalTrials.gov Identifier:
NCT05126667
Other Study ID Numbers:
  • UID 2762
First Posted:
Nov 19, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021