Use of Imatinib to Convert Triple Negative Breast Cancer Into ER-positive Breast Cancer (I-CONIC)

Inclusion Criteria

• •1. Histological confirmed invasive primary triple negative breast cancer≥15 mm) with any node status.
• •2. Age ≥18 years
• •Triple Negative subtype is defined below:
• •1. Hormone receptor status: the invasive tumour shall be ER- and progesterone receptor (PR) -negative \[staining present in \<10% by immunohistochemistry (IHC)\].
• •2. HER2 status: the invasive tumour shall be Human Epidermal growth factor Receptor (HER) 2-negative by the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) guidelines
• •3. No previous systemic treatment for TNBC
• •4. No concurrent anti-cancer treatment. Treatment with Bisphosphonates may continue.
• •5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• •6. Normal organ function as defined below:
• •1. absolute white blood cell count ≥1.5 x 109/L
• •2. platelets ≥100 x 109/L
• •3. haemoglobin ≥90g/dL
• •4. total bilirubin ≤1.5 x institutional upper normal limit (UNL)/dL (≤ 3 x UNL for patients with Gilbert´s syndrome)
• •5. ASAT, ALAT, GGT and alkaline phosphatase levels \< 1.5 × institutional UNL.
• •6. albumin \>2.5mg/dL
• •7. Creatinine \< 110 μmol/L
• •8. T3, T4 and TSH (only patients with previous thyroid dysfunction)
• •7. Patients of childbearing potential must have a negative serum or urine pregnancy test within 8 days prior to start of imatinib treatment..
• •Female patients of childbearing potential must agree to usecontraceptive methods with a failure rate below 1% per year during the study treatment and at least 90 days after the last dose of imatinib.
• •8. Patients must be able to take (swallow) an oral medication.
• •9. Patients must be capable to understand and comply with the protocol and has signed the informed consent.