TOP-1: Omission of radiotherapy in elderly patients with low risk breast cancer
Recruiting
- Conditions
- Elderly, Breast, Cancer, Radiotherapy
- Registration Number
- NL-OMON24515
- Lead Sponsor
- eiden University Medical Center (LUMC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1200
Inclusion Criteria
1. Low-risk invasive breast cancer: tumour < 1 cm, grade 1-2 or tumour 1-2 cm, grade 1
2. Registration within 3 months after Breast Conserving Surgery
3. R0 resection
4. HER2 negative
5. pN0 or pN0(itc) disease
6. ER positive > 50%
7. Age ≥70 years
8. Indication for standard radiotherapy
9. Willing to complete quality of life questionnaires and geriatric assessments
10. Female
Exclusion Criteria
1. Indication for hormonal therapy
2. Bilateral
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary aim: to assess whether radiotherapy can be safely omitted after breast conserving surgery in elderly patients with a very low risk of local recurrence
- Secondary Outcome Measures
Name Time Method Secondary aim: assessment of: quality of life, toxicity, geriatric assessment, overall- and breast cancer specific survival, distant metastasis free survival, relating biomarkers to outcome (tumor characteristics, at least: IHC ER, PR, HER2 and Ki-67), additional state of the art molecular analysis if possible, development and validation of local recurrence rate prediction models, (cost) efficacy (comparison with historical control group) and implementation of findings into standard care