Status:
COMPLETED
PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients (PRIMe)
Lead Sponsor:
West German Study Group
Collaborating Sponsors:
Agendia
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
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 HE...
Eligibility Criteria
Inclusion
- Women with histologically proven invasive stage 1 and 2 breast cancer
- Hormone receptor positive according to local standards
- HER2 negative - i.e. IHC 0-1+, or FISH or other ISH non-amplified (locally assessed)
- Axillary lymph node status: 0-3 involved (macro metastases i.e. \>2mm OR micro metastases i.e. \>0.2-2mm)
- ≥ 18 years of age at time of consent
- Patients must be eligible to receive adjuvant chemotherapy and endocrine therapy as defined by a good Karnofsky index, no hematological, cardiological or hepatic contraindications nor any impeding comorbidity
- Written informed consent
Exclusion
- ≥4 involved axillary nodes
- Multi-centric disease with more than 2 clinically relevant lesions
- HR negative OR HER2 positive/amplified (locally assessed)
- Previous diagnosis of malignancy unless disease free for 10 years
- Metastatic disease
- Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
- Women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy for current breast cancer
Key Trial Info
Start Date :
April 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2016
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT02269813
Start Date
April 1 2015
End Date
September 30 2016
Last Update
August 13 2019
Active Locations (3)
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1
Medizinische Universität Innsbruck Universitätsklinik für Frauenheilkunde
Innsbruck, Austria, 6020
2
Breast Center of the University of Munich (LMU)
Munich, Germany, 81377
3
Kantonsspital St.Gallen
Sankt Gallen, Switzerland, 9007