Partial Breast Radiotherapy in Low-risk Breast cancer group using a MR-guided adaptive approach; a phase II study
- Conditions
- Breast cancer
- Registration Number
- NL-OMON26191
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Early and early-delayed toxicity (CTCAE v. 4.0)
- Secondary Outcome Measures
Name Time Method Cosmetic outcome (panel scoring, BCCT.core software and patient self-evaluation) and quality of life (EORTC-QoL C30 & Breast Cancer module QLQ BR23)