Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy

Study Overview
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Brief Summary
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To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy

Detailed Description
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To evaluate cosmetic outcomes following conservative surgery (with or without oncoplastic surgery) for breast cancer with intraoperative radiotherapy (INTRABEAM) followed by hypofractionated external beam radiotherapy

Official Title
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Cosmetic Outcomes Following Conservative Surgery (With or Without Oncoplastic Surgery) for Breast Cancer With Intraoperative Radiotherapy (INTRABEAM) Followed by Hypofractionated External Beam Radiotherapy: a Phase II Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Intraoperative Radiotherapy (IORT)
* Procedure: Breast conservative surgery
* Radiation: External Beam Hypofractionated Radiotherapy (EBRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically-confirmed diagnosis of invasive breast carcinoma and eligibility for conservative surgery (with or without oncoplastic surgery) and radiotherapy. Not pregnant at diagnosis. Signed informed consent form. Age ≥45 years old. Patients candidates to Intrabeam. Patients with ≥60 years with the presence of one or more of the following adverse criteria after surgery: Tumor size > 2.5 cm. Extensive intraductal carcinoma (≥25%) Lymphovascular invasion. Involved focal margins (<2mm) without ampliation surgery. Exclusion Criteria: Presence of distant metastasis. Primary chemotherapy. Lymph node involvement. Negative hormonal receptors. Diagnosis of any other infiltrating tumour except for adequately resected squamous or basal cell epitheliomas Patients with collagen vascular disease (systemic lupus erythematosus, scleroderma, dermatomyositis). Uncontrolled infection. Concurrent treatment with other experimental treatments Lack of signed informed consent form.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Intraoperative Radiotherapy (IORT)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoperative Radiotherapy (IORT)<br>Patients with diagnosis of invasive breast cancer (IBC) will be treated with conservative surgery (with or without oncoplastic surgery) and 20 Gy IORT followed by hypofractionated radiotherapy. | Radiation: Intraoperative Radiotherapy (IORT)<br>* The Intrabeam Photon Radiosurgery System will deliver 20 Gy in the act of breast surgery<br>Procedure: Breast conservative surgery<br>* Breast conservative surgery with the aim of resecting breast tumour and with or without oncoplastic surgery<br>Radiation: External Beam Hypofractionated Radiotherapy (EBRT)<br>* A External Beam Hypofractionated Radiotherapy will be administered after surgery. y. The dose per fraction will be 2.67 Gy per session. EBRT will be performed daily from Monday to Friday for fifteen fractions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Cosmetic results - BCCT | It will be measured by the BCCT.core software programme. This software uses 4 photographies of the breast for each timepoint and evaluates cosmetic outcome based upon symmetry, skin colour changes and surgical scar appearance. The lower the calculated score, the better the cosmetic outcome (1=excellent, 2=good, 3=fair, 4=poor) | Baseline and every 12 months until 60 months | 
| Changes in Cosmetic results - Self Evaluation using YBT | Questionnaire for cosmetic self-evaluation from the Young Boost Trial (YBT) that consists s of 8 questions about various aspects (size, shape, skin colour, massiveness of the breast, nipple position, general appearance, visibility of the surgical scar, and overall satisfaction) to evaluate the degree of satisfaction of the patients themselves about the cosmetic results. | Baseline and every 12 months until 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Quality of life (QOL) - General | It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-C30 | Baseline and every 12 months until 60 months | 
| Toxicity (acute and late) | Defined according to the NCI criteria published in the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | Baseline and every 12 months until 60 months | 
| Local control | Defined as histologically-confirmed evidence of tumour recurrence in the ipsilateral breast | Baseline and every 3 months after completion of EBRT and thereafter every 6 months for 5 years | 
| Changes in Quality of life (QOL) - Breast | It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-BR23 | Baseline and every 12 months until 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraoperative radiotherapy, hypofractionated radiotherapy