Trials / Completed
CompletedNCT02269813
PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients (PRIMe)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 452 (actual)
- Sponsor
- West German Study Group · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
PRIMe is a prospective, case-only trial designed to measure the impact of MammaPrint on physician chemotherapy intention in the two discordant groups (ET/POOR, CT/GOOD) in stage 1 and 2 HR-positive HER2-negative breast cancer patients. The design also provides for assessment of several important secondary indicators. Eligible patients will have their tumor sample analyzed for MammaPrint, BluePrint and TargetPrint. Patients cannot start treatment before the MammaPrint result is received and taken into consideration for the adjuvant treatment plan.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | MammaPrint | |
| OTHER | BluePrint | |
| OTHER | TargetPrint |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2016-03-31
- Completion
- 2016-09-30
- First posted
- 2014-10-21
- Last updated
- 2019-08-13
Locations
3 sites across 3 countries: Austria, Germany, Switzerland
Source: ClinicalTrials.gov record NCT02269813. Inclusion in this directory is not an endorsement.