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, with specific survival of 98% at 5 years. The treatment of these tumors combines breast-conserving surgery and external whole breast irradiation for 6.5 weeks. A true de-escalation of treatment is taking place with these tumors, both surgically and medically. Surgery therefore now prefers breast-conserving methods in combination with exeresis of the sentinel lymph node only. In the same way, in many international studies, radiotherapy has been evaluating the possibility of reducing both: * the irradiation volume at the excision site (partial irradiation) * the duration of this irradiation (accelerated radiotherapy) Between 2004 and 2007, the CRLC \[Regional Anti-Cancer Center\] evaluated the feasibility and the oncological results of intra-operative partial irradiation via a phase II study in women 65 years of age and older with T1N0M0 hormone-sensitive tumors with a good prognosis. From 2010 to 2013, the ICM carried out an observational study of these tumors with an excellent prognosis. In July 2009, the American Society for Radiation Oncology (ASTRO) published a consensus statement with specific recommendations and indications for accelerated partial breast irradiation (APBI). This APBI technique has been developing in France over the past 5 years within the framework of clinical studies and in compliance with the 2012 recommendations of the French National Cancer Institute. This APBI can be given by 3D external radiotherapy or, as in this study, by intra-operative radiotherapy (IORT) in order to obtain optimal precision and spare as much of the surrounding healthy tissue as possible. The Investigator therefore propose a cohort study to prospectively analyze the results of this technique applied to the indications strictly defined by the ASTRO.
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 tumor site. follow up after this treatment during 5 years
Study Type
OBSERVATIONAL
Enrollment
519
All patients will have local excision of the primary tumor following appropriate clinical work-up. Surgery will be done according to usual local practice with a complete excision of the tumor. The aim of the local excision should be to achieve a minimum free margin of 2 mm whilst maintaining a good cosmetic outcome.
20 Gy of per-operative partial irradiation at the tumor site during the surgery
Icm Val D'Aurelle
Montpellier, Herault, France
Number of Patient With a Local Intra-mammary Relapse
The local relapse rate, defined as the number of intramammary relapses in the treated breast (regardless of quadrant and including skin), appreciated at 5 years and 10 years. It will be assessed according to the recommendations applied to the Centre
Time frame: post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)
Cosmetic Results
Evaluation of the cosmetic result of questionnaire (0 "no satisfy with the cosmetic result"" from 10 "very satisfy with the cosmetic result")
Time frame: post surgery : 3 weeks, 6 months and 12 months
Patients' Satisfaction Towards the Treatment
Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)
Time frame: post surgery : 3 weeks, 6 months and 12 months
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
Assessment of the impact of this accelerated treatment on maintaining the autonomy of the subject by the use of geriatric scale (ADL (Activities of Daily Living), IADL (instrumental Activities of Daily Living)). (scale from 0 "no autonomy" to 10 "good autonomy")
Time frame: post surgery : 3 weeks, 6 months and 12 months
Overall Survival
rate of death
Time frame: from baseline to 10 years after treatment
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