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TOP-1: Omission of radiotherapy in elderly patients with low risk breast cancer


- candidate number25598
- NTR NumberNTR6147
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-nov-2016
- Secondary IDsNL58117.058.16 BOOG 2016-01
- Public TitleTOP-1: Omission of radiotherapy in elderly patients with low risk breast cancer
- Scientific TitleTOP-1: Omission of radiotherapy in elderly patients with low risk breast cancer
- ACRONYMTOP-1
- hypothesisRadiotherapy (RT) can safely be omitted after breast conserving surgery (BCS) in elderly patients at low risk of developing a local recurrence (LR)
- Healt Condition(s) or Problem(s) studiedOlder adults, Breast cancer, Radiotherapy
- Inclusion criteria1. 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 criteria1. Indication for hormonal therapy
2. Bilateral
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-dec-2016
- planned closingdate
- Target number of participants800
- InterventionsOmitting adjuvant radiotherapy
- Primary outcomePrimary 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 outcomeSecondary 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
- TimepointsThe 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)
- Trial web sitehttps://www.boogstudycenter.nl/studie/283/top-1.html
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Datacenter Heelkunde
- CONTACT for SCIENTIFIC QUERIES Datacenter Heelkunde
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- Publications
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD24-nov-2016 - 7-feb-2017


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