breast cancer, partial breast radiotherapy, pre-operative borstkanker, partiele borst bestraling, pre-operatief
Conditions
Interventions
The additional procedures in this study are:
1. Biopsies before radiotherapy
2. Cytology at day 2 and 12 of radiotherapy
3. MRI before operation
4. A Pet scan will be done twice
5. Also, the sentinel procedure will take place before radiotherapy.
Sponsors
NKI-AVL
Plesmanlaan 121
1066 CX Amsterdam
Amsterdam, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: Patients ≥ 60 years of age with proven adenocarcinoma of the breast presenting with an unifocal lesion on mammogram and MRI (no diffuse microcalcifications), tumor size up till 3.0 cm.
Exclusion criteria
Exclusion criteria: 1. Age < 60 year; 2. Multifocal disease; 3. Lobulair carcinoom; 4. pN+.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response after radiotherapy will histologically be evaluated. Local control will be evaluated during follow-up. Cosmetic evaluation will take place including digital photographs which will be analyze using computer software as well as questionnaires for the patient and treating physician. | — |
Secondary
| Measure | Time frame |
|---|---|
| mRNA gene expression profiles, miRNA expression profiles and DNA copy number changes associated with response to radiotherapy defined as pathologic response assessed in the lumpectomy 6 weeks after radiotherapy will be identified. 60 Patients will be studied as a test set to identify predictive profiles. Responders are defined as Complete Respons and >50% Partial Response 6 weeks after radiotherapy. It is estimated, based on literature, that 50% of the patients will be defined responders. 60 Patients will be studied as a test set to identify predictive profiles; 60 patients will be used as a validation set. | — |
Contacts
Public ContactPaula Elkhuizen
Plesmanlaan 121
Outcome results
None listed