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MRI-guided single dose preoperative radiotherapy in low-risk breast cancer

Phase 2
Withdrawn
Conditions
10006291
Breast cancer
mammary neoplasm
Registration Number
NL-OMON46628
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
70
Inclusion Criteria

Female, ><= 50years, breast cancer, ER positive tumor, Her2 negative tumor, tumor maximum 3cm in diameter, BR grade 1 or 2

Exclusion Criteria

Indication for chemotherapy, lobular carcinoma, previous breast cancer, lymph node or distant metastasis, BRCA1, BRCA2 or CHEK2 gene mutation

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Pathologic complete response.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Radiologic response, relation between radiologic response and pathologic<br /><br>response, relation between pathology of biopsy and surgical specimen, toxicity,<br /><br>relation between immunoresponse and pathologic response, relation between<br /><br>circulation tumor DNA and pathologic response, cosmetic result, quality of<br /><br>life, workability or frailty (depending on age), disease free survival, overall<br /><br>survival.</p><br>
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