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

Use of Imatinib to Convert Triple Negative Breast Cancer Into ER-positive Breast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Triple Negative Breast Cancer
• Intervention / Treatment: Drug: Imatinib 400 MG Oral Tablet

Detailed Description

This is a single centre Window-of-Opportunity trial that will investigate the efficacy and feasibility of short term (10 days) imatinib in patients with newly diagnosed TNBC planned for surgery, with tumours ≥ 15 mm, any status in the axilla and when neoadjuvant treatment not is considered as an option. Imatinib is given at a dose of 400 mg daily.

The primary aim is to determine the proportion of patients that converts to ER positive breast cancer in the removed breast cancer tissue at surgery.

The secondary aim is to evaluate the safety and adverse events (AE) will be collected throughout the study, from informed consent until 30 days after the last dose of the IMP imatinib.

AEs will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barbro K Linderholm, MD, PhD; Phone Number: +46706045422; Email: barbro.linderholm@oncology.gu.se
• Study Contact Backup: Name: Elisabeth Kapocs; Phone Number: 8678 +46-31-3420000; Email: elisabeth.kapocs@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Recruiting
    • Barbro Linderholm
    • Contact: Elisabeth Kapocs; Phone Number: 8678 +46-31-3420000; Email: elisabeth.kapocs@vgregion.se
    • Contact: Barbro K Linderholm, MD, PhD; Phone Number: 7941 +46-31-3420000; Email: barbro.linderholm@oncology.gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short term Imatinib; Imatinib 400 mg x 1 for 10 days before surgery.	Drug: Imatinib 400 MG Oral Tablet; One tablet daily 10 days before surgery.; Other Names: No other intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the proportion of patients that convert to ER expressing breast cancer	ER expression is determined by immunohistochemistry	From surgery of the first patient to up to 100 weeks thereafter.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	AEs are registered according to National Cancer Institute (NCI) CTCAE version 5.0.	From time of the first included patient to up to 100 weeks thereafter.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory analyses - gene expression profiles	Gene expression profiles in tissue - biopsy and surgical specimen.	From surgery of the first patient to up to 100 weeks thereafter.
Exploratory analyses - gene expression profiles	Gene expression profiles determined in circulating tumour-DNA	From time of the first included patient to up to 100 weeks thereafter.

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: Lund University; Sahlgrenska University Hospital
• Investigators: Principal Investigator: Barbro K Linderholm, MD, PhD, Sahlgrenska University Hospital

Publications and helpful links

General Publications

• Roswall 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.
• Jansson 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.
• Arnedos 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 28, 2029
• Study Completion (Estimated): December 28, 2029

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Conversion of TNBC to Luminal BC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Tyrosine Kinase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: EudraCT 2020-005200-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No