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

August 12, 2019 updated by: West German Study Group
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
452

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Medizinische Universität Innsbruck Universitätsklinik für Frauenheilkunde
  • Germany
      • Munich, Germany, 81377
        • Breast Center of the University of Munich (LMU)
  • Switzerland
      • St. Gallen, Switzerland, 9007
        • Kantonsspital St.Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Up to 6 months after end of treatment.
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.
Time Frame: Up to 6 months after end of treatment.
Up to 6 months after end of treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measure the impacts of MammaPrint on adjuvant treatment decisions (physician chemotherapy intention) and compare with previous trials involving MammaPrint or other tests.
Time Frame: Up to 6 months after end of treatment.
The planned analysis includes assessment of the incremental cost-effectiveness (ICER) of MammaPrint within a health economic context (i.e., taking cost and quality-adjusted life years into account).
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.
Time Frame: Up to 6 months after end of treatment.
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).
Time Frame: Up to 6 months after end of treatment.
Up to 6 months after end of treatment.
Assess investigators' confidence in treatment recommendations before and after MammaPrint results were known via questionnaire.
Time Frame: Up to 6 months after end of treatment.
Up to 6 months after end of treatment.
Assess concordance of final treatment intention and treatment actually received by number of patients.
Time Frame: Up to 6 months after end of treatment.
Up to 6 months after end of treatment.
Assess concordance of TargetPrint ER, PR and HER2 results with locally assessed IHC/FISH ER, PR and HER2 by number of patients.
Time Frame: Up to 6 months after end of treatment.
Up to 6 months after end of treatment.
Compare clinical subtype based on IHC/FISH ER, PR, HER2 and Ki-67 (St Gallen 2013) with BluePrint molecular subtype by diagnostic definition of subtype.
Time Frame: Up to 6 months after end of treatment.
Up to 6 months after end of treatment.
Assess concordance of MammaPrint, BluePrint and TargetPrint in multi-centric breast cancer by number of patients.
Time Frame: Up to 6 months after end of treatment.
Up to 6 months after end of treatment.
Assess the combined switch rate in the two concordant groups (ET/GOOD) and (CT/POOR) and verify that it is lower than the switch rate in both discordant groups by number of patients.
Time Frame: Up to 6 months after end of treatment.
Up to 6 months after end of treatment.
Perform descriptive sub-analysis in pre- and post-menopausal women by switch percentages.
Time Frame: Up to 6 months after end of treatment.
Up to 6 months after end of treatment.
Perform cross-validation with other adjuvant breast cancer studies by switch rate, if available.
Time Frame: Up to 6 months after end of treatment.
Up to 6 months after end of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West German Study Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Agendia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nadia Harbeck, Prof. Dr., Scientific Director
  • Study Chair: Ulrike Nitz, Prof. Dr., General Manager/Medical Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WSG-PRIMe

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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