Preoperative Image guided Accelerated Partial Breast Irradiation (PAPBI) in elderly women with early stage Breast cancer; defining radiotherapy sensitivity

Phase 2

Completed

Conditions: Breast cancer
10006291
mammary malignancy

Registration Number: NL-OMON32678

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Patients >=60 years of age with proven adenocarcinoma of the breast presenting with an unifocal lesion on mammogram and MRI (no diffuse microcalcifications), tumor size 1.0-3.0 cm.

Exclusion Criteria

age < 60 year, multifocal disease, lobulair carcinoom, pN+

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>mRNA gene expression profiles, miRNA expression profiles and DNA copy number<br /><br>changes associated with response to radiotherapy defined as pathologic response<br /><br>assessed in the lumpectomy 6 weeks after radiotherapy will be identified. 60<br /><br>Patients will be studied as a test set to identify predictive profiles.<br /><br><br /><br>Responders are defined as Complete Respons and >50% Partial Response 6 weeks<br /><br>after radiotherapy. It is estimated, based on literature, that 50% of the<br /><br>patients will be defined responders. 60 Patients will be studied as a test set<br /><br>to identify predictive profiles; 60 patients will be used as a validation set.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Cosmetic evaluation will take place including digital photographs which will<br /><br>be analyze using computer software as well as questionnaires for the patient<br /><br>and treating physician.<br /><br><br /><br>Quality of life questionnaires.</p><br>