Breast conserving therapy using Accelerated Partial Breast Irradiation (APBI) in elderly patients: a feasibility study

Completed

• Conditions: mammacarcinoom; 10006291; 10006295; Breast cancer

• Registration Number: NL-OMON45136
• Lead Sponsor: Haaglanden Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 509

Inclusion Criteria

Histological confirmed breast cancer (DCIS and invasive) ductal subtypes
T1-2 smaller than 30mm as determined by ultrasound
N0 on palpation and ultrasound examination
Unicentric, Unifocal disease (radiological), multifocal when limited within 2 cm of the index lesion)
Age * 60
Any hormonal receptor status, hormonal therapy allowed following Dutch treatment guidelines
Technically eligible for lumpectomy or radiotherapy
No contra indications for lumpectomy and sentinal node procedure
Written informed consent
Willing to fill out the QOL, geriatric- and co morbidity questionaires - if applicable

Exclusion Criteria

Patients not eligible / fit for lumpectomy and sentinal node procedure
pT2 (>30mm), pT3 and pT4
Positive surgical margins
Multi centricity; multifocal (> 2cm from the index lesion)
Extensive intraductal carcinoma; lympho-vascular invasion
Previous treatment of ipsilateral breast tumor (DCIS or invasive)
Paget disease of the nipple
Cutaneous involvement
Distant metastases; > pN1a
Previous radiotherapy on the ipsilateral breast
neo adjuvant chemotherapy for current malignancy
Collagen diseases (systematic erythematosus lupus, scleroderma, dermatomyositis)
Psychiatric diseases or other that prevents signing of informed consent
Other neoplasm's in the last 5 year with exception of skin tumors (excl melanoma) and intraepthelial lesions of the cervix uteri

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Confirm favorable tumor control and cosmetic outcome (< 5% grade >2 toxicity, <<br /><br>5% local recurrence (5yr), > 90% good/excellent cosmetic result). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Gathering QOL, geriatric and other information for modeling patient outcome.<br /><br>EORTC QOL C30/ breast module, ACE 27, registration multi-pharmacy, geriatric<br /><br>screening questionnaire (incl. GFI ,G8 and VES 13). Also digital pictures will<br /><br>be made after 3 and 5 years for objective cosmetic results.</p><br>