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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Invasive Breast Cancer, Breast-conserving Surgery

Intervention / Treatment
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* Procedure: tumorectomy with axillary dissection (sentinel lymph node)
* Radiation: per-operative partial irradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: -. 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 GROUP<br>Patient with an Invasive breast cancer with a good prognosis that is accessible to breast-conserving surgery. The treatment combines extended tumorectomy with axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial irradiation at the tumor Follow up after this treatment will scheduled 10 years | Procedure: tumorectomy with axillary dissection (sentinel lymph node)<br>* 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.<br>Radiation: per-operative partial irradiation<br>* 20 Gy of per-operative partial irradiation at the tumor site during the surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local intra-mammary relapse rate | 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 | post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total) | 
| Local intra-mammary relapse rate | The local relapse rate, defined as the number of intramammary relapses in the homolateral lymph node, appreciated at 5 years and 10 years. It will be assessed according to the recommendations applied to the Centre | post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic results | Evaluation of the cosmetic result of questionnaire (0 from 10) | post surgery : 3 weeks, 6 months and 12 months | 
| Survival without metastatic relapse | Study of survival without metastatic relapse, of overall survival, of specific survival | post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total) | 
| patients' satisfaction towards the treatment | Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy) | 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, IADL). | post surgery : 3 weeks, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, good prognosis, surgery, intra-operative partial irradiation