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

NCT05126667 | Completed

• 1 other identifier: UID 2762
• Study Type: observational
• Target: 9,710
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (6)

• Cumulative incidence of ipsilateral breast tumor recurrence

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

  10 years

• 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

• Cumulative incidence of contralateral breast cancer

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

  10 years

• Rate of distant metastasis

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

  10 years

• 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

• Rate of overall survival

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

  10 years

Study Arms (2)

Breast-conserving surgery

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

Procedure: Breast-conserving surgery

Mastectomy

Patients who underwent mastectomy

Procedure: Mastectomy

Interventions

Breast-conserving surgery PROCEDURE

Breast conserving surgery plus whole breast irradiation

Breast-conserving surgery

Mastectomy PROCEDURE

Breast mastectomy

Mastectomy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospectively analysis of patients who received treatment for invasive breast cancer at the European Institute of Oncology between January 1, 2000, and December 31, 2008. The original cohort comprised 9710 eligible patients with breast cancer, of whom 2289 (23.6%) underwent breast conserving surgery + whole breast irradiation and 7421 (76.4%) underwent mastectomy alone. After propensity score matching, 1970 of the 2289 patients who underwent mastectomy (86.1%) were successfully matched to 1970 patients who underwent breast conserving surgery.

You may qualify if:

• First primary breast cancer
• pT1-2
• pN0-3a
• Surgery performed at European Institute of Oncology between 2000 and 2008

You may not qualify if:

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

Sponsors & Collaborators

• European Institute of Oncology: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental; Mastectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Francesca Magnoni, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: November 19, 2021
• Study Start: January 1, 2000
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share