breast cancer
Conditions
Interventions
Preoperative, single dose, ablative partial breast radiotherapy.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Females at least 50 years of age, with an unifocal cT1N0M0 non-lobular breast cancer on mammogram/ultrasound/MRI and sentinel node biopsy • Females at least 70 years of age, with an unifocal cT1-2(maximum 3 cm)N0M0 non-lobular breast cancer on mammogram/ultrasound/MRI and sentinel node biopsy • Tumor with negative Her2neu receptor and positive estogen receptor • Adequate communication and understanding skills of the Dutch language
Exclusion criteria
Exclusion criteria: • Legal incapacity • BRCA gene mutation. • WHO performance scale > 2. • Previous history of breast cancer • Other type of malignancy within 5 years before breast cancer diagnosis. • Previous history of ipsilateral breast surgery and impaired cosmetic outcome, as assessed by the treating surgeon or radiation-oncologist • Extensive DCIS component. • Invasive lobular carcinoma. • MRI absolute contraindications as defined by the Radiology Department. • Multicentricity or multifocality on MRI. • Nodal or other organ involvement with cytological or histological confirmation. • Treatment with neo-adjuvant chemo- and immunotherapy. . • Indication adjuvant chemo- and immunotherapy (endocrine treatment is allowed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective is to evaluate the pathologic complete response rates following single dose ablative partial breast radiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: • Rate of radiological response on MRI. • Quality of life assessment. • Acute- and late-toxicity assessment. • Cosmetic outcome assessment. • Frailty assessment in study population • Local -, regional - and distant relapse rates. • Disease free - and overall survival rates. Tertiary endpoint: • Future research on radiotherapy- associated genotyping. | — |
Countries
Netherlands
Outcome results
None listed