No registrations found.
ID
Source
Brief title
Health condition
Elderly, Breast, Cancer, Radiotherapy
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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
Background summary
The main focus of the present trial is a first step towards treatment de-escalation in older breast cancer patients.
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 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.
Study objective
Radiotherapy (RT) can safely be omitted after breast conserving surgery (BCS) in elderly patients at low risk of developing a local recurrence (LR)
Study design
The primary endpoint is the local recurrence rate (LRR) at 5 years. Secondary determinants are the distant metastases free survival (DMFS), breast cancer-specific survival (BCSS) and overall survival (OS)
Intervention
Omitting adjuvant radiotherapy
Clinical Research Center Heelkunde LUMC
Postzone K-6-R, Postbus 9600
Leiden 2300 RC
The Netherlands
071 526 3500
ClinicalResearchCenter@lumc.nl
Clinical Research Center Heelkunde LUMC
Postzone K-6-R, Postbus 9600
Leiden 2300 RC
The Netherlands
071 526 3500
ClinicalResearchCenter@lumc.nl
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5983 |
| NTR-old | NTR6147 |
| CCMO | NL58117.058.16 |
| OMON | NL-OMON53002 |