Use of Imatinib to convert triple negative breast cancer into ER-positive breast cancer - I-CONIC

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vaestra Goetalandsregionen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

22 Aug 2022 → ongoing

Decision date (initial)

2024-10-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

The Swedish cancer society

External identifiers

EU CT number

2024-511141-19-00

EudraCT number

2020-005200-19

ClinicalTrials.gov

NCT05722795

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To determine the proportion of patients that converts to Estrogen Receptor (ER)-positive breast cancer in the removed breast cancer tissue at surgery

Secondary objectives 2

1. To determine the safety and toxicity of short term exposure to imatinib
2. To determine other ER-related genes/proteins, gene expression profiles, immune response and circulating tumor DNA (ctDNA) as part of a translational program

Conditions and MedDRA coding

Primary breast cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Histological confirmed invasive primary triple negative breast cancer (≥15 mm) with any node status.
2. Age ≥ 18 years old
3. 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]
4. No previous systemic treatment for TNBC
5. No concurrent anti-cancer treatment
6. Treatment with Bisphosponates may continue
7. ECOG performace status 0-1
8. 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)
9. Patients of childbearing potential must have a negative serum or urine pregnancy test within 8 days of initiating imatinib therapy
10. 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
11. Patients must be able to take (swallow) an oral medication
12. Patients must be capable to understand and comply with the protocol and has signed the informed consent

Exclusion criteria 9

1. Patients suitable for neoadjuvant treatment / inclusion in NordicTRIP
2. HER2 positive or luminal (ER/PR positive) breast cancer
3. Concomitant treatment for breast cancer within 14 days before registration
4. Unable to adhere to the study procedures
5. 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
6. Pregnancy and breast feeding
7. 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)
8. Known human immune deficiency positivity
9. Known active Hepatitis B or Hepatitis C

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Immunohistochemistry fraction of Estrogen Receptor is changed from 0% to 2% or more after imatinib treatment
2. Immunohistochemistry fraction of Estrogen Receptor is changed from 1-9% to ≥10% after imatinib treatment
3. Immunohistochemistry fraction of Estrogen Receptor 1-9% increase with at least 2%, coupled with a significant increase luminal gene transcripts

Secondary endpoints 2

1. Safety analyses according to common terminology criteria for adverse events (CTCAE) v.5: up to 30 days after the last dose of imatinib.
2. Identification of predictive markers for conversion by evaluation of molecular characteristics (gene expression profiles, intrinsic subtypes and proliferation) and immune response in tissue and blood before start of imatinib and in the surgical specimen.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vaestra Goetalandsregionen

Sponsor organisation

Vaestra Goetalandsregionen

Address

Regionens Hus

City

Vänersborg

Postcode

462 80

Country

Sweden

Scientific contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Barbro Linderholm

Public contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Barbro Linderholm

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications