Imatinib for conversion of triple negative breast cancer into oesrogen dependent breast cancer - "I-CONIC"

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005200-19-SE

Enrollment

Registered

2020-12-18

Start date

2022-05-09

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Triple Negative Breast Cancer planned for surgery.

Interventions

Trade Name: Imatinib Product Name: Imatinib Product Code: L01XE01 Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria • Histologically confirmed invasive primary triple negative breast cancer =15 mm with any node status. • Age =18 years old. • Triple negative subtype is defined below: o Hormone receptor status: the invasive tumour shall be ER- and PR-negative [staining present in 2.5mg/dL o Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Exclusion criteria • HER2 positive or luminal (ER/PgR positive) breast cancer. • Concomitant treatment for breast cancer within 14 days before registration. • Unable to adhere to the study procedures. • 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. • Pregnancy and breast feeding. • Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ and a cancer diagnosed and definitively treated = 5 years before randomization with no subsequent evidence of recurrence. • Known human immune deficiency positivity. • Known active Hepatitis B or Hepatitis C.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the proportion of patients that convert from Triple Negative to oestrogen dependent breast cancer.;Secondary Objective: Toxicity of short-term (10 days) treatment with imatinib. Exploratory analyses: Identification of predictive markers for conversion by evaluation of molecular characteristics (gene expression profiles, immune response, proliferation).;Primary end point(s): ER-positivity at surgery after pre-treatment with imatinib [time frame from base-line to surgery]. ER is assessed according to the international guide-lines and by gene expression profiles. ;Timepoint(s) of evaluation of this end point: From base-line biopsy to surgery [2 weeks]	—

Measure

Time frame

Main Objective: To determine the proportion of patients that convert from Triple Negative to oestrogen dependent breast cancer.;Secondary Objective: Toxicity of short-term (10 days) treatment with imatinib. Exploratory analyses: Identification of predictive markers for conversion by evaluation of molecular characteristics (gene expression profiles, immune response, proliferation).;Primary end point(s): ER-positivity at surgery after pre-treatment with imatinib [time frame from base-line to surgery]. ER is assessed according to the international guide-lines and by gene expression profiles. ;Timepoint(s) of evaluation of this end point: From base-line biopsy to surgery [2 weeks]

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Secondary

Measure	Time frame
Secondary end point(s): Toxicity and safety of short term exposure to imatinib [time frame 6 weeks] Side effects are assessed and graded according to the National Cancer Institute CTCAE version 5. Exploratory analyses (gene expression profiles including intrinsic subtypes, immune response, proliferation) in relation to proportion of patients in whom tumours are successfully converted to oestrogen dependent breast cancer.;Timepoint(s) of evaluation of this end point: Toxicity - from first dose of imatinib to 30 days after the last dose of imatinib [time frame 6 weeks]. Exploratory analyses: Laboratory analyses will be completed within 6 months from the last dose of imatinib for the last included patient.	—

Measure

Time frame

Secondary end point(s): Toxicity and safety of short term exposure to imatinib [time frame 6 weeks] Side effects are assessed and graded according to the National Cancer Institute CTCAE version 5. Exploratory analyses (gene expression profiles including intrinsic subtypes, immune response, proliferation) in relation to proportion of patients in whom tumours are successfully converted to oestrogen dependent breast cancer.;Timepoint(s) of evaluation of this end point: Toxicity - from first dose of imatinib to 30 days after the last dose of imatinib [time frame 6 weeks]. Exploratory analyses: Laboratory analyses will be completed within 6 months from the last dose of imatinib for the last included patient.

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Countries

Sweden

Contacts

Public ContactMrs Annika Baan

Clinical Trial Unit, Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden

annika.baan@vgregion.se+46700906097

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026