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

Breast Cancer Clinical Trial

— I-CONIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05722795
• Other study ID #: EudraCT 2020-005200-19
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2022
• Source: Vastra Gotaland Region
• Contact: Barbro K Linderholm, MD, PhD
• Phone: +46706045422
• Email: barbro.linderholm[@]oncology.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Imatinib 400 MG Oral Tablet
One tablet daily 10 days before surgery.

Locations

Country	Name	City	State
Sweden	Barbro Linderholm	Gothenburg

Sponsors (3)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Lund University, Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View Citation

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 — View Citation

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, Moc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Primary	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	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.