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

Breast Cancer Clinical Trial

— IMPACt  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670577
• Other study ID #: IMPACt
• Status: Completed
• Start date: November 2015
• Est. completion date: August 2017

Study information

• Verified date: June 2018
• Source: Agendia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 481
• Est. completion date: August 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Akron General Medical Center	Akron	Ohio
United States	Essex Oncology	Belleville	New Jersey
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Western Maryland Health System	Cumberland	Maryland
United States	The Cancer Center at DeKalb Medical	Decatur	Georgia
United States	St. Mary Medical Center	Langhorne	Pennsylvania
United States	Sparrow Cancer Center	Lansing	Michigan
United States	Methodist Hospital	Merrillville	Indiana
United States	University of Miami	Miami	Florida
United States	Aurora Cancer Care	Milwaukee	Wisconsin
United States	Columbia St. Mary's	Milwaukee	Wisconsin
United States	Community Healthcare System	Munster	Indiana
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Desert Regional Medical Center	Palm Springs	California
United States	St. Clair Hospital	Pittsburgh	Pennsylvania
United States	St. Joseph's Women's Hospital	Tampa	Florida
United States	Cadence Cancer Center	Warrenville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Agendia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Treatment Decision	Compare treatment decision before and after test results.	6 weeks