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

Launched by VASTRA GOTALAND REGION · Feb 1, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at whether a medicine called imatinib can change a certain type of breast cancer, known as triple negative breast cancer (TNBC), into a form that has a receptor called estrogen receptor (ER) positive. ER-positive breast cancers often respond to different treatments than triple negative types. The study involves patients who have recently been diagnosed with triple negative breast cancer tumors that are at least 15 millimeters in size and who are planning to have surgery. The main goal is to see how many patients’ tumors change to ER-positive after taking imatinib for a short time before surgery.

People who might be eligible for this study are adults with a confirmed diagnosis of triple negative breast cancer (meaning their cancer cells do not have estrogen, progesterone, or HER2 receptors), with tumors 15 mm or larger, and who have not had any previous treatment for this cancer. Participants should be well enough to take oral medication and agree to follow the study’s instructions, including using birth control if they can have children. During the trial, patients will take imatinib for a short period before their surgery, and then doctors will examine the removed tissue to check for any changes. This study is currently recruiting, and it offers a chance to explore a new approach that might open up more treatment options for people with this challenging type of breast cancer.

Gender

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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)
• • 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.
• Exclusion Criteria:
• • 1. Patients suitable for neoadjuvant treatment.
• • 2. Concomitant treatment for breast cancer within 14 days before registration.
• • 3. Unable to adhere to the study procedures.
• • 4. Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance.
• • 5. Pregnancy and breast-feeding.
• • 6. Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
• • 7. Known human immunodeficiency virus (HIV) positivity.
• • 8. Known active Hepatitis B or Hepatitis C