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