Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05722795

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

Led by Vastra Gotaland Region · Updated on 2025-07-09

40

Participants Needed

1

Research Sites

343 weeks

Total Duration

On this page

Sponsors

V

Vastra Gotaland Region

Lead Sponsor

S

Sahlgrenska University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed invasive primary triple negative breast cancer with tumor size 15 mm or larger, any lymph node status
  • Age 18 years or older
  • Triple negative subtype defined by ER- and PR-negative status (less than 10% staining by immunohistochemistry) and HER2-negative status
  • No previous systemic treatment for triple negative breast cancer
  • No concurrent anti-cancer treatment (bisphosphonates allowed)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Normal organ function as specified by blood counts and liver, kidney tests
  • Negative pregnancy test within 8 days before starting imatinib for patients of childbearing potential
  • Female patients of childbearing potential must agree to use effective contraception during treatment and for at least 90 days after last dose
  • Ability to swallow oral medication
  • Ability to understand and comply with the protocol and provide informed consent
Not Eligible

You will not qualify if you...

  • Patients suitable for neoadjuvant treatment
  • Concurrent breast cancer treatment within 14 days before registration
  • Inability to follow study procedures
  • Medical conditions that could interfere with treatment or compliance
  • Pregnancy or breastfeeding
  • Concurrent malignancies requiring therapy (except non-invasive or in situ carcinoma)
  • Known HIV infection
  • Known active Hepatitis B or Hepatitis C infection

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Barbro Linderholm

Gothenburg, Sweden, 41345

Actively Recruiting

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Research Team

B

Barbro K Linderholm, MD, PhD

CONTACT

E

Elisabeth Kapocs

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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