Status:

ACTIVE_NOT_RECRUITING

Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis

Lead Sponsor:

Institut du Cancer de Montpellier - Val d'Aurelle

Conditions:

Invasive Breast Cancer

Breast-conserving Surgery

Eligibility:

FEMALE

60+ years

Brief Summary

Due to screening, T1N0 early-stage breast cancer now accounts for more than 50% of the tumors diagnosed in France. The prognosis of these tumors is good, even excellent in women ≥ 65 years of age, wit...

Detailed Description

after registration, particpants have as treatment "combination extended tumorectomy with axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial irradiation at the tumo...

Eligibility Criteria

Inclusion

  • Women 60 years of age or older,
  • Histologically proven invasive ductal breast cancer or of a histologically favorable sub-type (mucinous, tubular or colloid),
  • . Unifocal tumor,
  • T1 (diameter ≤ 20 mm),
  • N0 (pN0 or pNi+),
  • M0,
  • Gland exeresis margins ≥ 2 mm,
  • Estrogen receptor positive,
  • Information and non-opposition of the patient.

Exclusion

  • . Inflammatory breast cancer,
  • Associated peri-tumoral lymphatic emboli
  • Associated extensive intra-ductal component
  • Invasive lobular carcinoma
  • Pure ductal carcinoma in situ,
  • Sarcoma or lymphoma-type non-epithelial tumor
  • Synchronous bilateral breast cancer,
  • Any prior neo-adjuvant treatment: radiotherapy, chemotherapy, hormone therapy

Key Trial Info

Start Date :

December 15 2009

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2030

Estimated Enrollment :

519 Patients enrolled

Trial Details

Trial ID

NCT04414202

Start Date

December 15 2009

End Date

December 1 2030

Last Update

April 2 2025

Active Locations (1)

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1

Icm Val D'Aurelle

Montpellier, Herault, France, 34398