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.