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Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using imatinib to convert triple-negative breast cancer into ER-positive breast cancer

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

Run by Vastra Gotaland Region · NCT05722795 · Data updated 2026-11-12

This gives 10 days of imatinib to people with newly diagnosed triple-negative breast cancer before surgery to see if their tumors become estrogen receptor (ER)–positive.

More Breast Cancer trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorVastra Gotaland Region
Government
Drugs / interventionsimatinib
Locations1 site (Gothenburg)
StatusRecruiting
StartedJune 1, 2023
Main results expectedJune 28, 2029
Study endsDecember 28, 2029
Registry record updatedJuly 9, 2025
Trial IDNCT05722795 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with newly diagnosed invasive triple-negative breast cancer measuring ≥15 mm who are planned for upfront surgery, have not received prior systemic therapy, and have ECOG performance status 0–1.

Probably not a fit

Patients with tumors smaller than 15 mm, prior systemic treatment, poor organ function, or those already planned for neoadjuvant therapy are unlikely to gain benefit from this short preoperative treatment.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center window-of-opportunity trial will test short-term imatinib given for 10 days before surgery in adults with newly diagnosed triple-negative breast cancer and tumors at least 15 mm. Participants take imatinib 400 mg orally once daily and then proceed to planned surgical removal of the tumor. The primary outcome is the proportion of tumors that convert from ER-negative to ER-positive on the surgical specimen, and adverse events are collected through 30 days after the last dose using CTCAE v5.0. Patients who have received prior systemic therapy or who require neoadjuvant treatment are not eligible.

Why it matters

Potential benefit: If successful, some patients with TNBC could become eligible for hormone therapies, potentially broadening treatment options.

How similar studies have gone: This is a novel clinical application of imatinib—while imatinib is effective in other cancers, few prior clinical studies have shown conversion of TNBC to ER-positive status.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Barbro Linderholm
    Gothenburg, Sweden     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.