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

NCT ID: NCT02670577

Last Updated: 2018-06-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 481 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-08-31

Brief 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.

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.

Conditions

Breast Cancer

Study Design

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

Study Groups

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

No interventions assigned to this group

HER2+

Histologically proven invasive T1a or T1b breast cancer

& Hormone receptor negative or positive

& HER2 positive

& Axillary lymph node status: 0-1 involved

No interventions assigned to this group

Triple Negative

Histologically proven invasive T1a or T1b breast cancer

& Hormone receptor negative

& HER2 negative

& Axillary lymph node status: 0-1 involved

No interventions assigned to this group

Neoadjuvant

Stage I or II patients receiving neoadjuvant therapy.

No interventions assigned to this group

Eligibility Criteria

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

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

Sponsors

Agendia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Desert Regional Medical Center

Palm Springs, California, United States

University of Miami

Miami, Florida, United States

St. Joseph's Women's Hospital

Tampa, Florida, United States

The Cancer Center at DeKalb Medical

Decatur, Georgia, United States

Cadence Cancer Center

Warrenville, Illinois, United States

Methodist Hospital

Merrillville, Indiana, United States

Community Healthcare System

Munster, Indiana, United States

Western Maryland Health System

Cumberland, Maryland, United States

Sparrow Cancer Center

Lansing, Michigan, United States

Essex Oncology

Belleville, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Akron General Medical Center

Akron, Ohio, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

St. Mary Medical Center

Langhorne, Pennsylvania, United States

St. Clair Hospital

Pittsburgh, Pennsylvania, United States

Aurora Cancer Care

Milwaukee, Wisconsin, United States

Columbia St. Mary's

Milwaukee, Wisconsin, United States

Countries

United States

References

Soliman H, Shah V, Srkalovic G, Mahtani R, Levine E, Mavromatis B, Srinivasiah J, Kassar M, Gabordi R, Qamar R, Untch S, Kling HM, Treece T, Audeh W. MammaPrint guides treatment decisions in breast Cancer: results of the IMPACt trial. BMC Cancer. 2020 Jan 31;20(1):81. doi: 10.1186/s12885-020-6534-z.

Reference Type: DERIVED

PMID: 32005181 (View on PubMed)

Other Identifiers

IMPACt

Identifier Type: -

Identifier Source: org_study_id