Tailored treatment in Older Patients TOP-1: Omission of radiotherapy in elderly patients with low risk breast cancer

Tailored treatment in Older Patients TOP-1: Omission of radiotherapy in elderly patients with low risk breast cancer - TOP-1

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53002

Enrollment

1200

Registered

2016-11-23

Start date

2017-01-12

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

radiotherapie breast cancer breast malignancy

Interventions

These patients will not receive adjuvant radiotherapy.

Eligibility

Age

65 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - age 70 years and older; - after breast conserving surgery - tumor 50% positive, HER2 negative; - sN0 or sN0(itc); - R0 resection; - female.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - indication for hormonal therapy; - bilateral.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the local recurrence rate (LRR) at 5 years.	—

Secondary

Measure	Time frame
Secondary determinants are the distant metastases free survival (DMFS), breast cancer-specific survival (BCS) and overall survival (OS), quality of life, side-effects, costs, cosmetic outcome, geriatric assessment and biomarkers	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)