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

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02670577

Run by

Agendia

People needed

481

Starts

2015-11-01

Expected to finish

2017-08-01

Last updated by the study team

2018-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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