Single-dose preoperative partial breast irradiation in low-risk breast cancer patients

Phase 2

Recruiting

• Conditions: breast cancer; breast carcinoma; 10006291

• Registration Number: NL-OMON54083
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

Female, 50 years or older, breast cancer, ER positive tumor, HER2-negative
tumor, maximal tumorsize 2 cm, Bloom Richardson grade 1 or 2

Exclusion Criteria

Indication for chemotherapy, lobular carcinoma, previous breast cancer, lymph
node or distant metastasis, breast cancer gene mutation, previous irradiation
of chest wall, breast implant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Rate of patients with pathologic complete response (pCR) following the<br /><br>single-dose preoperative radiotherapy treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Radiologic response, pathologic response in irradiated tumor tissue and<br /><br>excision specimen, immune response, circulating tumor DNA, toxicity, cosmetic<br /><br>result, quality of life, anxiety and depression, local and regional recurrence,<br /><br>disease free survival, overall survival.</p><br>