Preoperative fractionated Stereotactic Radiosurgery for Breast Cancer (PROBE)
- Conditions
- C50Malignant neoplasm of breast
- Registration Number
- DRKS00014558
- Lead Sponsor
- Städtisches Klinikum Dessau
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting withdrawn before recruiting started
- Sex
- Female
- Target Recruitment
- 50
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acute toxicity, dose finding<br>Follow up investigations 1-3 years after surgical intervention every 6 months<br>Follow up investigations 4-5 years after surgical intervention every 12 months<br>Follow up investigations 5-15 years after surgical intervention every 24 months<br>
- Secondary Outcome Measures
Name Time Method