Use of Imatinib to Convert Triple Negative Breast Cancer Into ER-positive Breast Cancer (I-CONIC)
Trial Parameters
Brief Summary
This is a single centre Window-of-Opportunity trial investigating the efficacy and feasibility of short term imatinib in patients with newly diagnosed triple negative breast cancer (TNBC) planned for surgery, with tumours ≥ 15 mm, any status in the axilla when neoadjuvant treatment not is considered as an option. The primary aim is to determine the proportion of patients that converts to estrogen receptor (ER) positive breast cancer in the removed breast cancer tissue at surgery.
Eligibility Criteria
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