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