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PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients (PRIMe)

NCT02269813 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 452

Last updated 2019-08-13

No results posted yet for this study

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

OTHER

MammaPrint

OTHER

BluePrint

OTHER

TargetPrint

Sponsors & Collaborators

  • Agendia

    collaborator INDUSTRY

  • West German Study Group

    lead OTHER

Principal Investigators

  • Nadia Harbeck, Prof. Dr. · Scientific Director

  • Ulrike Nitz, Prof. Dr. · General Manager/Medical Director

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-01
Primary Completion
2016-03-31
Completion
2016-09-30

Countries

  • Austria
  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02269813 on ClinicalTrials.gov