IMATINIB for Primary breast cancer | Triple-negative breast cancer

Inclusion criteria

• {"criterion_text":"- Histological confirmed invasive primary triple negative breast cancer (≥15 mm) with any node status."}
• {"criterion_text":"- Female patients of childbearing potential must agree to use contraceptive methods with a failure rate below 1% per year during the study treatment and at least 90 days after the last dose of imatinib"}
• {"criterion_text":"- Patients must be able to take (swallow) an oral medication"}
• {"criterion_text":"- Patients must be capable to understand and comply with the protocol and has signed the informed consent"}
• {"criterion_text":"- Age ≥ 18 years old"}
• {"criterion_text":"- Triple negative breast cancer subtype defined as ER- and PR-negative [staining present in <10% by immunohistochemistry (IHC), and HER2-negative defined by the ASCO CAP guidelines]"}
• {"criterion_text":"- No previous systemic treatment for TNBC"}
• {"criterion_text":"- No concurrent anti-cancer treatment"}
• {"criterion_text":"- Treatment with Bisphosponates may continue"}
• {"criterion_text":"- ECOG performace status 0-1"}
• {"criterion_text":"- Normal organ function defined as follows: absolute white blood cell count ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, haemoglobin ≥90 g/dL, total bilirubin ≤1.5 x institutional UNL/dL (≤3 x UNL for patients with Gilbert´s sydrome), ASAT, ALAT, GGT and alkaline phosphatase levels <1.5 x institutional ULN, albumin >2.5 mg/dL, Creatinine <110 µmol/L, T3, T4 and TSH (only patients with previous thyroid dysfunction)"}
• {"criterion_text":"- Patients of childbearing potential must have a negative serum or urine pregnancy test within 8 days of initiating imatinib therapy"}

Exclusion criteria

• {"criterion_text":"- Patients suitable for neoadjuvant treatment / inclusion in NordicTRIP"}
• {"criterion_text":"- HER2 positive or luminal (ER/PR positive) breast cancer"}
• {"criterion_text":"- Concomitant treatment for breast cancer within 14 days before registration"}
• {"criterion_text":"- Unable to adhere to the study procedures"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Pregnancy and breast feeding"}
• {"criterion_text":"- Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ and a cancer diagnosed and definitely treated ≥ 5 years before inclusion with no subsequent evidence of recurrence)"}
• {"criterion_text":"- Known human immune deficiency positivity"}
• {"criterion_text":"- Known active Hepatitis B or Hepatitis C"}

Primary endpoints

• {"endpoint_text":"- Immunohistochemistry fraction of Estrogen Receptor is changed from 0% to 2% or more after imatinib treatment","definition_or_measurement_approach":"Measured by immunohistochemistry (IHC) on tumor tissue comparing ER fraction pre-treatment and in surgical specimen after imatinib; threshold change defined as 0% to ≥2%."}
• {"endpoint_text":"- Immunohistochemistry fraction of Estrogen Receptor is changed from 1-9% to ≥10% after imatinib treatment","definition_or_measurement_approach":"Measured by immunohistochemistry (IHC) on tumor tissue; conversion defined as increase from 1–9% ER staining to ≥10%."}
• {"endpoint_text":"- Immunohistochemistry fraction of Estrogen Receptor 1-9% increase with at least 2%, coupled with a significant increase luminal gene transcripts","definition_or_measurement_approach":"Combination of IHC ER fraction increase (≥2% within 1–9% range) assessed by IHC and molecular assessment of luminal gene transcripts (gene expression profiling) to confirm luminal transcriptional changes."}

Secondary endpoints

• {"endpoint_text":"- Safety analyses according to common terminology criteria for adverse events (CTCAE) v.5: up to 30 days after the last dose of imatinib.","definition_or_measurement_approach":"Adverse events graded per CTCAE v5, with safety follow-up up to 30 days post last imatinib dose."}
• {"endpoint_text":"- Identification of predictive markers for conversion by evaluation of molecular characteristics (gene expression profiles, intrinsic subtypes and proliferation) and immune response in tissue and blood before start of imatinib and in the surgical specimen.","definition_or_measurement_approach":"Molecular analyses including gene expression profiling, intrinsic subtype assessment, proliferation markers, and immune response evaluation in tissue and blood samples pre-treatment and in the surgical specimen."}

Sweden

Earliest CTIS Part Ii Submission Date

23-01-2024

Latest Decision Or Authorization Date

08-10-2024

Processing Time Days

259

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Vaestra Goetalandsregionen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden