Breast cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Good candidates for partial breast irradiation according to the GEC-ESTRO recommendations are patients selected in the low-risk group. In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age > 50 years - WHO performance score 0-2 - Pathology proven breast cancer with following histology: invasive ductal carcinoma, mucinous, tubular, medullary, colloid cc, and associated LCIS - Any histologic grade - Any hormonal receptor status - T-stage: Tumor size = 3cm (pT1-2) - N-stage: No positive lymph nodes examined by sentinel lymph node biopsy or axillary lymph node dissection (at least 6 nodes pathologically examined) - Radical resection of tumor with = 2mm surgical margin free of tumour - All patients should be able to undergo MRI scans - Ability to provide written informed consent. - Ability to perform breath-hold for at least 17 seconds
Exclusion criteria
Exclusion criteria: According to the GEC-ESTRO recommendations, subject who meets any of the following criteria will be excluded from participation in this study: - Breast cancer histology of invasive lobular carcinoma, ductal carcinoma in situ sec - Breast cancer with a multicentric or multifocality character - An extensive intraductal component in pathology examination - Lympho-vascular invasion in the pathology examination - Treatment with neoadjuvant chemotherapy before lumpectomy - Breast conserving surgery with an oncoplastic breast surgery technique - Re-excision of tumour in ipsilateral breast - Open surgical wound or wound infection - Previous irradiation in the ipsilateral breast - Contra-indications for MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early and early-delayed toxicity (CTCAE v. 4.0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cosmetic outcome (panel scoring, BCCT.core software and patient self-evaluation) and quality of life (EORTC-QoL C30 & Breast Cancer module QLQ BR23) | — |
Contacts
Amsterdam UMC, location VUmc