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

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

NCT ID: NCT05722795

Condition: Breast Cancer
Triple Negative Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Imatinib Mesylate

Conditions: Keywords:
Conversion of TNBC to Luminal BC

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Window-of-opportunity trial.

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Imatinib 400 MG Oral Tablet
Description: One tablet daily 10 days before surgery.
Arm group label: Short term Imatinib

Other name: No other intervention

Summary: 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.

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Barbro Linderholm

Address:
City: Gothenburg
Zip: 41345
Country: Sweden

Contact:
Last name: Barbro K Linderholm, MD, PhD

Phone: +46-31-3420000

Phone ext: 7941
Email: barbro.linderholm@oncology.gu.se

Contact backup:
Last name: Elisabeth Kapocs

Phone: +46-31-3420000

Phone ext: 8678
Email: elisabeth.kapocs@vgregion.se

Start date: February 6, 2023

Completion date: December 31, 2024

Lead sponsor:
Agency: Vastra Gotaland Region
Agency class: Other

Collaborator:
Agency: Sahlgrenska University Hospital, Sweden
Agency class: Other

Collaborator:
Agency: Lund University
Agency class: Other

Source: Vastra Gotaland Region

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05722795