early stage breast cancer
Conditions
Interventions
Intervention group receives PBSI treatment with spacer injection, control group
receives PBSI without spacer injection.
for more details see study protocol
Sponsors
Sint Franciscus Gasthuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Female * Age * 50 years * A confirmed histological diagnosis of * invasive ductal carcinoma (IDC), Papillary/tubular/cribriform/medullar carcinoma,DCIS or combination of these tumortypes * Treated by breast conserving surgery with axillary node dissection (with a minimum of 6 nodes sampled) or sentinel lymph node biopsy * A maximum tumor size of 3 cm * Clear surgical margins at ink for IDC and * 2 mm for DCIS, or re-excision negative * PBSI technically feasible * Node negative (axillary lymph node dissection or sentinel node biopsy), nodes with isolated tumor cells are eligible * Informed consent signed
Exclusion criteria
Exclusion criteria: * Lymphovascular invasion * Known allergy for hyaluronic acid * Neo-adjuvant chemotherapy * Active auto immune disorder with severe vasculitis component * Uncontrolled and complicated diabetes insulin-dependent * Pregnancy * Cosmetic breast implants * Pacemaker/ICD * Psychiatric or addictive disorder that would preclude attending follow-up * Post-operative wound infection or abscess following CDC criteria * Lobular features on histology (pure or mixed) or sarcoma histology * Triple negative tumors * Extensive in situ carcinoma * Multicentric disease (in more than one quadrant or separated by 2 cm or more)Bilateral breast cancer * Recurrent breast cancer * Paget*s disease of the nipple * Metastases or active other cancer (defined by malignancy in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of teleangiectasia, following Bentzen's four point scale (LENTSOMA), after 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Local recurrence, disease free and overall survival Side effects/ adverse events( including o Pain (acute and late) (LENTSOMA) o Redness o Skin induration (acute or late CTCAE 4.03): o Radiation dermatitis (acute) RTOG/EORTC ánd CTCAE 4.03: o Subcutaneaous induration (late ) RTOG/EORTC o Pigmentation (acute and late) LENTSOMA/Bentzen : o Surgical Site Infection (Acute) CDC Cosmetic and functional results Health related Quality of Life Cost effectiveness Validation of a Dutch translation of the BCTOS questionnaire Skin dose | — |
Countries
Netherlands
Outcome results
None listed