Preoperative Breast Irradiation - the PROBI trial
Phase 2
Completed
- Conditions
- breast cancer10006291
- Registration Number
- NL-OMON47915
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 94
Inclusion Criteria
* Histologically proven invasive breast carcinoma
* cT1-2N0 breast cancer
* cM0
* Female patients * 50 years
* Planned breast conserving surgery
* Ability to undergo irradiation and surgery
* Signed written informed consent
Exclusion Criteria
* Prior surgery or radiotherapy for the protocol tumor (neoadjuvant chemotherapy or endocrine therapy is allowed)
* planned oncoplastic reduction mammoplasty
* cTis
* Extensive calcifications on mammogram (Birads 3, 4 or 5)
* cT3-4 and/or cN1-3 invasive carcinoma
* Distant metastases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Postoperative surgical complications within 6 weeks after surgery</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Radiological response (MRI)<br /><br>* Pathological response<br /><br>* Delay in planned surgery<br /><br>* Cosmetic outcome, including fibrosis/induration<br /><br>* Breast pain<br /><br>* Local relapse free survival<br /><br>* Disease free survival<br /><br>* Distant metastases free survival<br /><br>* Overall survival</p><br>