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

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