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
Enrollment
262
Actual Duration (Months)

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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