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

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.

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