Clinical trial · Interventional
Use of Imatinib to Convert Triple Negative Breast Cancer Into ER-positive Breast Cancer (I-CONIC)
Use of Imatinib to Convert Triple Negative Breast Cancer Into ER-positive Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib 400 MG Oral Tablet | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Short term Imatinib
- description
- Imatinib 400 mg x 1 for 10 days before surgery.
- interventionNames
- Drug: Imatinib 400 MG Oral Tablet
Primary outcomes (1)
- measure
- To determine the proportion of patients that convert to ER expressing breast cancer
- timeFrame
- From surgery of the first patient to up to 100 weeks thereafter.
- description
- ER expression is determined by immunohistochemistry
Secondary outcomes (1)
- measure
- Adverse events
- timeFrame
- From time of the first included patient to up to 100 weeks thereafter.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTRoswall P, Bocci M, Bartoschek M, Li H, Kristiansen G, Jansson S, Lehn S, Sjolund J, Reid S, Larsson C, Eriksson P, Anderberg C, Cortez E, Saal LH, Orsmark-Pietras C, Cordero E, Haller BK, Hakkinen J, Burvenich IJG, Lim E, Orimo A, Hoglund M, Ryden L, Moch H, Scott AM, Eriksson U, Pietras K. Microenvironmental control of breast cancer subtype elicited through paracrine platelet-derived growth factor-CC signaling. Nat Med. 2018 May;24(4):463-473. doi: 10.1038/nm.4494. Epub 2018 Mar 12. PMID 29529015
- RESULTJansson S, Aaltonen K, Bendahl PO, Falck AK, Karlsson M, Pietras K, Ryden L. The PDGF pathway in breast cancer is linked to tumour aggressiveness, triple-negative subtype and early recurrence. Breast Cancer Res Treat. 2018 Jun;169(2):231-241. doi: 10.1007/s10549-018-4664-7. Epub 2018 Jan 29. PMID 29380207
- RESULTArnedos M, Roulleaux Dugage M, Perez-Garcia J, Cortes J. Window of Opportunity trials for biomarker discovery in breast cancer. Curr Opin Oncol. 2019 Nov;31(6):486-492. doi: 10.1097/CCO.0000000000000583. PMID 31464762