C50
Conditions
Interventions
Group 1: Test arm: therapy of the primary tumor with SBRT dose escalation.
The respective doses are administered on 5 consecutive working days, according to the intervention period.
Dose level 1: 5
Sponsors
Städtisches Klinikum Dessau
Eligibility
Sex/Gender
Female
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: age = 50 years Invasive ductal, monofocal carcinoma of the breast G1– G3, cT1c to cT2 (1 cm to 4 cm) without any evidence of lobular carcinoma or in situ DCIS (>10%) Complete histological characterization including: ER expression status, PR expression status, Her-2/neu expression status, Ki-67 und PD-L1 cN0 no indication for preoperative chemotherapy The patient is candidate for primary breast-conserving resection and sentinel lymph node biopsy. Ability to understand protocol and ability and willingness to comply with follow-up The patient agrees, that her case will be discussed repeatedly in interdisciplinary tumor boards. Negative pregnancy test in premenopausal patients If premenopausal and sexually active, maintained contraception for at least 12 months after radiotherapy The patient agrees to have an Au-tissue marker placed to define localization oft the tumor.
Exclusion criteria
Exclusion criteria: previous radiotherapy of affected breast Pregnancy test positive rheumatoide arthritis, systemic lupus erythematoides, scleroderma breast implant of affected breast Lack of tissue marker at the start of radiotherapy Planned mastectomy or skin-sparing mastectomy Planning constrains cannot be achieved (Drop-out after planning) Inability to tolerate prone positioniong during radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute toxicity, dose finding Follow up investigations 1-3 years after surgical intervention every 6 months Follow up investigations 4-5 years after surgical intervention every 12 months Follow up investigations 5-15 years after surgical intervention every 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| - Regression score - local tumor control rates at 5 years - DFS - OS - late toxicity according to Common Terminology Criteria for Adverse Events of the National Cancer Institute, Version 4.0 - QOL using EORTC QLQ-C30 - Cosmetic changes after 1, 3, & 5 yrs (BCCT.core) - immunological assessment at diagnosis: Histology: ratio of tumor cells to non-tumorous tissue, ER, PR, Her-2/neu, Ki-67; PD-L1, CD8 pos. cells, CD4 pos. cells, CD11 pos. cells, CD25 pos. cells, CD56 pos. cells, IHC staining of factor VIII, TGF-beta, FGF, IFN-beta und IFN-gamma, TNF-alpha, cleaved caspase-3 - Immunological assessment of the surgical specimen: ratio of tumor cells to non-tumorous tissue, ER, PR, Her-2/neu, Ki-67; PD-L1, CD8 pos. cells, CD4 pos. cells, CD11 pos. cells, CD25 pos. cells, CD56 pos. cells, IHC staining of CD34, TGF-beta, FGF, IFN-beta und IFN-gamma, TNF-alpha, cleaved caspase-3 Follow up investigations 1-3 years after surgical intervention every 6 months Follow up investigations 4-5 years after surgical intervention every 12 months Follow up investigations 5-15 years after surgical intervention every 24 months | — |
Countries
Germany
Contacts
Public ContactIlja Ciernik
Städtisches Klinikum Dessau
Outcome results
None listed