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

NCT ID: NCT02269813

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 452 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-01
• Study Completion Date: 2016-09-30

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

ET/GOOD

Endocrine therapy only.

MammaPrint

Intervention Type: OTHER

BluePrint

Intervention Type: OTHER

TargetPrint

Intervention Type: OTHER

CT/POOR

Chemoendocrine therapy according to national guidelines.

MammaPrint

Intervention Type: OTHER

BluePrint

Intervention Type: OTHER

TargetPrint

Intervention Type: OTHER

Interventions

MammaPrint

Intervention Type: OTHER

BluePrint

Intervention Type: OTHER

TargetPrint

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Agendia

INDUSTRY

Sponsor Role: collaborator

West German Study Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadia Harbeck, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Scientific Director

Ulrike Nitz, Prof. Dr.

Role: STUDY_CHAIR

General Manager/Medical Director

Locations

Medizinische Universität Innsbruck Universitätsklinik für Frauenheilkunde

Innsbruck, , Austria

Breast Center of the University of Munich (LMU)

Munich, , Germany

Kantonsspital St.Gallen

Sankt Gallen, , Switzerland

Countries

Austria; Germany; Switzerland

Other Identifiers

WSG-PRIMe

Identifier Type: -

Identifier Source: org_study_id