MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I

Inclusion Criteria:

- Women with histologically proven invasive breast cancer and no distant metastases
and;

- lymphnode negative and a clinical tumor classification of T2 (≥3.5cm)-T4 or with 1-3
positive lymph nodes and a clinical tumor classification of T2-T4 DCIS or LCIS are
allowed in addition to invasive cancer at T2 or T3 level.

- Age ≥ 18 years. At least one lesion that can be accurately measured in two dimensions
utilizing mammogram, ultrasound, or MRI images to define specific size and validate
complete pathologic response.

- Adequate bone marrow reserves (neutrophil count >1.5 x109 /l and platelet count >100
x109/l), adequate renal function (serum creatinine ≤ 1.5 x upper limit of normal) and
hepatic function (ALAT, ASAT ≤ 2.5 x upper limit of normal, alkaline phosphatase ≤
2.5 x upper limit of normal and total bilirubin ≤ 2.0 x upper limit of normal).

- Signed informed consent of the patient

Exclusion Criteria:

- Any patient with confirmed metastatic disease. Patients with inflammatory breast
cancer.

- Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails Quality
Assurance or Quality Control criteria.

- Patients who have had any prior chemotherapy, radiotherapy, or endocrine therapy for
the treatment of breast cancer.

- Any serious uncontrolled intercurrent infections, or other serious uncontrolled
concomitant disease.