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

Active, not recruiting

Conditions: Invasive Breast Cancer
Breast-conserving Surgery

Interventions: Procedure: tumorectomy with axillary dissection (sentinel lymph node)
Radiation: per-operative partial irradiation

Registration Number: NCT04414202

Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

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, 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: 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

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: Female

Target Recruitment: 519

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1 GROUP	per-operative partial irradiation	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
1 GROUP	tumorectomy with axillary dissection (sentinel lymph node)	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

Primary Outcome Measures

Name	Time	Method
Number of Patient With a Local Intra-mammary Relapse	post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)	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

Secondary Outcome Measures

Name	Time	Method
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients	post surgery : 3 weeks, 6 months and 12 months	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")
Overall Survival	from baseline to 10 years after treatment	rate of death
Cosmetic Results	post surgery : 3 weeks, 6 months and 12 months	Evaluation of the cosmetic result of questionnaire (0 "no satisfy with the cosmetic result"" from 10 "very satisfy with the cosmetic result")
Patients' Satisfaction Towards the Treatment	post surgery : 3 weeks, 6 months and 12 months	Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)