Breast Cancer
Conditions
Keywords
Intraoperative radiotherapy, hypofractionated radiotherapy
Brief summary
To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy
Detailed description
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
Interventions
RADIATIONIntraoperative Radiotherapy (IORT)
The Intrabeam Photon Radiosurgery System will deliver 20 Gy in the act of breast surgery
PROCEDUREBreast conservative surgery
Breast conservative surgery with the aim of resecting breast tumour and with or without oncoplastic surgery
RADIATIONExternal Beam Hypofractionated Radiotherapy (EBRT)
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.
Sponsors
Institut Català d'Oncologia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intraoperative Radiotherapy (IORT)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Cosmetic results - BCCT | Baseline and every 12 months until 60 months | 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) |
| Changes in Cosmetic results - Self Evaluation using YBT | Baseline and every 12 months until 60 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Quality of life (QOL) - General | Baseline and every 12 months until 60 months | It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-C30 |
| Toxicity (acute and late) | Baseline and every 12 months until 60 months | Defined according to the NCI criteria published in the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 |
| Local control | Baseline and every 3 months after completion of EBRT and thereafter every 6 months for 5 years | Defined as histologically-confirmed evidence of tumour recurrence in the ipsilateral breast |
| Changes in Quality of life (QOL) - Breast | Baseline and every 12 months until 60 months | It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-BR23 |
Countries
Spain
Contacts
Primary ContactEvelyn Martínez, MD
Outcome results
None listed