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Use of Imatinib to convert triple negative breast cancer into ER-positive breast cancer - I-CONIC
EU CTIS ID: 2024-511141-19-00
What this study is testing
To determine the proportion of patients that converts to Estrogen Receptor (ER)-positive breast cancer in the removed breast cancer tissue at surgery
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histological confirmed invasive primary triple negative breast cancer (≥15 mm) with any node status.
- 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
- Age ≥ 18 years old
- 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]
You likely can't join if
- Patients suitable for neoadjuvant treatment / inclusion in NordicTRIP
- HER2 positive or luminal (ER/PR 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
See the full eligibility criteria
- Histological confirmed invasive primary triple negative breast cancer (≥15 mm) with any node status.
- 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
- Age ≥ 18 years old
- 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]
- No previous systemic treatment for TNBC
- No concurrent anti-cancer treatment
- Treatment with Bisphosponates may continue
- ECOG performace status 0-1
- 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)
- Patients of childbearing potential must have a negative serum or urine pregnancy test within 8 days of initiating imatinib therapy
- Patients suitable for neoadjuvant treatment / inclusion in NordicTRIP
- HER2 positive or luminal (ER/PR 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 definitely treated ≥ 5 years before inclusion with no subsequent evidence of recurrence)
- Known human immune deficiency positivity
- Known active Hepatitis B or Hepatitis C
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.