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Brief Title: PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients (PRIMe)
Official Title: PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients (PRIMe)
Study ID: NCT02269813
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Medizinische Universität Innsbruck Universitätsklinik für Frauenheilkunde, Innsbruck, , Austria
Breast Center of the University of Munich (LMU), Munich, , Germany
Kantonsspital St.Gallen, St. Gallen, , Switzerland
Name: Nadia Harbeck, Prof. Dr.
Affiliation: Scientific Director
Role: PRINCIPAL_INVESTIGATOR
Name: Ulrike Nitz, Prof. Dr.
Affiliation: General Manager/Medical Director
Role: STUDY_CHAIR