NCT02941835
Terminated
Not Applicable
Preoperative Breast Irradiation, the PROBI Trial. A Phase I/II Feasibility Trial
ConditionsBreast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- The Netherlands Cancer Institute
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Postoperative surgical complications
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
The PROBI is a phase I/II trial assessing the feasibility of preoperative whole breast irradiation in female patients with low to intermediate risk breast cancer, who undergo breast conserving therapy, including a boost dose of irradiation.
An additional goal of this study is to assess tumor response to radiotherapy, by imaging modalities (PET-CT and MRI) and pathology
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically proven invasive breast carcinoma
- •cT1-2N0 breast cancer
- •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
- •extensive calcifications on mammagram (Birads 3,4 or 5)
- •cT3-4 and/or cN1-3 invasive carcinoma
- •distant metastasis
Outcomes
Primary Outcomes
Postoperative surgical complications
Time Frame: within six weeks after surgery
postoperative complication will be scored by a specific list
Secondary Outcomes
- Radiological response(6 weeks post-radiation)
- Pathological response(at surgery)
- cosmetic outcome(1,3 and 5 years post-treatment)
Study Sites (1)
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