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

NCT02269813 | Completed

• 1 other identifier: WSG-PRIMe
• Study Type: observational
• Target: 452
• Locations: 3 countries
• Sites: 3

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

Keywords

MammaPrint; BluePrint; TargetPrint

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 6 months after end of treatment.

• Assess the incremental cost-effectiveness of MammaPrint in terms of cost and quality-adjusted life years within a health economic context using the impacts measured in this trial as well as the predictive impact demonstrated in previous trials.

  Up to 6 months after end of treatment.

Secondary Outcomes (11)

• Measure the impacts of MammaPrint on adjuvant treatment decisions (physician chemotherapy intention) and compare with previous trials involving MammaPrint or other tests.

  Up to 6 months after end of treatment.

• Measure rate (by incidence) and severity (by Common Toxicity Criteria) of treatment-related serious adverse events stratified by whether or not patient received adjuvant chemotherapy.

  Up to 6 months after end of treatment.

• Assess change in patients' decisional conflict status and anxiety levels before and after MammaPrint results via questionnaire, stratified by the four groups (2 concordant and 2 discordant).

  Up to 6 months after end of treatment.

• Assess investigators' confidence in treatment recommendations before and after MammaPrint results were known via questionnaire.

  Up to 6 months after end of treatment.

• Assess concordance of final treatment intention and treatment actually received by number of patients.

  Up to 6 months after end of treatment.

Study Arms (2)

ET/GOOD

Endocrine therapy only.

Other: MammaPrint; Other: BluePrint; Other: TargetPrint

CT/POOR

Chemoendocrine therapy according to national guidelines.

Other: MammaPrint; Other: BluePrint; Other: TargetPrint

Interventions

MammaPrint OTHER

CT/POOR; ET/GOOD

BluePrint OTHER

CT/POOR; ET/GOOD

TargetPrint OTHER

CT/POOR; ET/GOOD

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will comprise patients for whom the investigator will advise either endocrine therapy or chemotherapy + endocrine therapy. Patients confirmed to be low/high risk by the gene signature will receive the respective treatment. Patients with discordant results will be investigated for investigator's chemotherapy intention after MammaPrint results are available.

You may qualify if:

• 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

You may not qualify if:

• ≥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

Sponsors & Collaborators

• West German Study Group: lead
• Agendia: collaborator

Study Sites (3)

Medizinische Universität Innsbruck Universitätsklinik für Frauenheilkunde

Innsbruck, 6020, Austria

Location

Breast Center of the University of Munich (LMU)

Munich, 81377, Germany

Location

Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blueprint Asept

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nadia Harbeck, Prof. Dr.

  Scientific Director

  PRINCIPAL INVESTIGATOR

• Ulrike Nitz, Prof. Dr.

  General Manager/Medical Director

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 21, 2014
• Study Start: April 1, 2015
• Primary Completion: March 31, 2016
• Study Completion: September 30, 2016
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

AU (1); CH (1); DE (1)