Preoperative Accelerated Partial Breast Irradiation in patients with locally recurrent or second primary breast cancer

Phase 2

• Conditions: Recurrent breast cancer. Ipsilateral breast tumor recurrence.; 10006291; 10006295

• Registration Number: NL-OMON56628
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 31

Inclusion Criteria

• Female patients >= 51 years
• Ipsilateral breast cancer; recurrence or second primary
• Histologically proven invasive adenocarcinoma
• Histologically proven estrogen receptor positive, HER2-negative
• Tumor size <= 3 cm
• Grade I or grade II (biopsy)
• cN0M0
• Unifocal lesions on mammogram and MRI
• Interval since completion of local treatment of primary tumor > 12 months
• Previous radiotherapy (whole breast or partial) of the ipsilateral breast
• Repeat breast conserving surgery feasible

Exclusion Criteria

• >= grade 3 radiotherapy toxicity in the breast
• Previous boost radiotherapy is not allowed, UNLESS the protocol tumor lies
outside of the original boost area
• Distant metastases and/or synchronous contralateral invasive or in situ
carcinoma
• Lobular invasive carcinoma or pleiomorph LCIS
• Pure DCIS
• Triple negative or HER2neu positive subtype
• Lymphovascular invasion in biopsy
• Neoadjuvant systemic treatment for the protocol tumor (except for admission
of pre-surgery hormonal therapy <= 2 months)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Acute post-treatment toxicity up to 3 months after end of local treatment,<br /><br>assessed by the CTCAE v5.0. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Fibrosis/induration<br /><br>• Quality of life<br /><br>• Cosmetic outcome according to the BCCT.core software program </p><br>