Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry (IMPACt)

June 26, 2018 updated by: Agendia

The scope of this study is to measure the impact of MammaPrint on treatment in Hormone Receptor (HR)-positive HER2-negative breast cancer patients.

In addition, the impact of MammaPrint on treatment in patients with T1a/T1b and pN0/pN1 (up to 1 node), Triple Negative or HER2-positive tumors will be assessed.

Study Overview

Status

Completed

Conditions

Detailed Description

Eligible patients will have their tumor sample analyzed for MammaPrint, BluePrint and TargetPrint. Patients cannot start treatment before the MammaPrint and BluePrint result is received and taken into consideration for the treatment plan. The clinical data are to be entered online. There will be 2 Case Report Forms (CRFs). Baseline clinical data and physician chemotherapy intention before knowing the MammaPrint and BluePrint result will be entered in CRF 1. After completion of CRF1, the MammaPrint and BluePrint result will be released. CRF2 will be completed after the final treatment decision has been made. This CRF will capture physician chemotherapy intention after the MammaPrint and BluePrint result and the impact of these results.

A sample size of 331 patients is required to detect a 25% overall treatment change (5% significance and 95% power) in stage I and II HR-positive, HER2-negative patients receiving adjuvant therapy.

In addition at least 50 T1a/bN0/1 (up to 1 node) Triple Negative, at least 50 T1a/bN0/1 (up to 1 node) HER2-positive breast cancer patients, and at least 50 patients receiving neoadjuvant therapy will be enrolled.

Study Type

Observational

Enrollment (Anticipated)

481

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

  • United States
    • California
      • Palm Springs, California, United States, 92262
        • Desert Regional Medical Center
    • Florida
      • Miami, Florida, United States, 33442
        • University of Miami
      • Tampa, Florida, United States, 33607
        • St. Joseph'S Women'S Hospital
    • Georgia
      • Decatur, Georgia, United States, 30033
        • The Cancer Center at DeKalb Medical
    • Illinois
      • Warrenville, Illinois, United States, 60555
        • Cadence Cancer Center
    • Indiana
      • Merrillville, Indiana, United States, 46410
        • Methodist Hospital
      • Munster, Indiana, United States, 46321
        • Community Healthcare System
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Western Maryland Health System
    • Michigan
      • Lansing, Michigan, United States, 48911
        • Sparrow Cancer Center
    • New Jersey
      • Belleville, New Jersey, United States, 07109
        • Essex Oncology
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
    • Ohio
      • Akron, Ohio, United States, 44302
        • Akron General Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma
    • Pennsylvania
      • Langhorne, Pennsylvania, United States, 19047
        • St. Mary Medical Center
      • Pittsburgh, Pennsylvania, United States, 15102
        • St. Clair Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Aurora Cancer care
      • Milwaukee, Wisconsin, United States
        • Columbia St. Mary's

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Stage I or II HR-positive, HER2-negative breast cancer patients AND T1a/b, N0/N1 (up to 1 node) Triple Negative, or HER2-positive breast cancer patients

Description

Inclusion Criteria:

  • Eligible to receive chemotherapy and endocrine therapy as defined by a good Karnofsky index (≥80) and no hematologic, cardiologic or hepatic contraindications, nor any impeding comorbidity
  • Informed consent form signed on the same day or before enrollment
  • ≥ 18 years of age at time of consent Per study arm
  • Histologically proven invasive stage I and II breast cancer and Hormone Receptor positive (ER+ PR-, ER- PR+ or ER+ PR+) according to local standards & HER2 negative: IHC 0-1+, or FISH or other ISH non-amplified (locally assessed)

IMPACt study; version 1 2015 September 1 Page 10 Axillary lymph node status: 0-3 involved (macro metastases i.e. >2mm OR micro metastases i.e. >0.2-2mm)

OR

Histologically proven invasive T1a or T1b breast cancer & Hormone receptor negative (ER- and PR-) according to local standards & HER2 negative: IHC 0-1+, or FISH or other ISH non-amplified (locally assessed)

& Axillary lymph node status: 0-1 involved (macro metastases i.e. >2mm OR micro metastases i.e. >0.2-2mm)

OR

Histologically proven invasive T1a or T1b breast cancer

& Hormone receptor negative or positive (ER-PR-, ER+PR-, ER-PR+, ER+PR+) according to local standards

& HER2 positive: IHC 3+, or FISH or other ISH amplified (locally assessed)

& Axillary lymph node status: 0-1 involved (macro metastases i.e. >2mm OR micro metastases i.e. >0.2-2mm)

Exclusion Criteria:

  • Previous diagnosis of breast 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

Cohorts and Interventions

Group / Cohort
stage I or II HR-positive, HER2-negative

Histologically proven invasive stage I and II breast cancer and Hormone Receptor positive & HER2 negative

& Axillary lymph node status: 0-3 involved
HER2+

Histologically proven invasive T1a or T1b breast cancer

& Hormone receptor negative or positive

& HER2 positive

& Axillary lymph node status: 0-1 involved
Triple Negative

Histologically proven invasive T1a or T1b breast cancer

& Hormone receptor negative

& HER2 negative

& Axillary lymph node status: 0-1 involved
Neoadjuvant
Stage I or II patients receiving neoadjuvant therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Treatment Decision
Time Frame: 6 weeks
Compare treatment decision before and after test results.
6 weeks

Collaborators and Investigators

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

Sponsor

Agendia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2015

Primary Completion (Actual)

April 30, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Actual)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPACT

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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