Imatinib for conversion of triple negative breast cancer into oesrogen dependent breast cancer - I-CONIC
- Conditions
- Early Triple Negative Breast Cancer planned for surgery.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-005200-19-SE
- Lead Sponsor
- Västra Götalandsregionen/Onkologiska kliniken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
Inclusion criteria
•Histologically confirmed invasive primary triple negative breast cancer =15 mm with any node status.
•Age =18 years old.
•Triple negative subtype is defined below:
oHormone receptor status: the invasive tumour shall be ER- and PR-negative [staining present in <10% by immunohistochemistry (IHC)].
oHER2 status: the invasive tumour shall be HER2-negative by the ASCO CAP guidelines
•No previous systemic treatment for TNBC.
•No concurrent anti-cancer treatment.
•Treatment with Bisphosphonates may continue.
•ECOG performance status 0-1
•Normal organ function as defined below:
oabsolute white blood cell count =1.5 x 109/L
oplatelets =100 x 109/L
ohaemoglobin =90g/dL
ototal bilirubin =1.5 x institutional UNL/dL (= 3 x UNL for patients with Gilbert´s syndrome)
oASAT, ALAT, GGT and alkaline phosphatase levels < 1.5 × institutional ULN.
oalbumin >2.5mg/dL
oCreatinine < 110 µmol/L
oT3, T4 and TSH (only patients with previous thyroid dysfunction)
•Patients of childbearing potential must have a negative serum or urine pregnancy test within 8 days of initiating imatinib therapy.
•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.
•Patients must be able to take (swallow) an oral medication.
•Patients must be capable to understand and comply with the protocol and has signed the informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
•HER2 positive or luminal (ER/PgR positive) breast cancer.
•Concomitant treatment for breast cancer within 14 days before registration.
•Unable to adhere to the study procedures.
•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.
•Pregnancy and breast feeding.
•Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ and a cancer diagnosed and definitively treated = 5 years before randomization with no subsequent evidence of recurrence.
•Known human immune deficiency positivity.
•Known active Hepatitis B or Hepatitis C.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method