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

Women's Cancer Study Group GmbH452 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

452

Conditions

Breast Cancer

Interventions

MammaPrintOTHER

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * ≥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

Locations (3)

Medizinische Universität Innsbruck Universitätsklinik für Frauenheilkunde

Innsbruck, Austria

Breast Center of the University of Munich (LMU)

Munich, Germany

Kantonsspital St.Gallen

Sankt Gallen, Switzerland

Outcomes

Primary Outcomes

Measure the impact of MammaPrint on adjuvant treatment decisions in discordant groups (ET/POOR and CT/GOOD) in stage-1/2, HR+, HER2- breast cancer and test whether these impacts each exceed a pre-determined compliance threshold.

Compliance, assessed in terms of the fraction of patients in each discordant group whose physicians switch their chemotherapy intention following MammaPrint test disclosure is used to measure the impact of MammaPrint on adjuvant treatment decisions.