Breast CancerI-CONICNCT05722795
Use of Imatinib to Convert Triple Negative Breast Cancer Into ER-positive Breast Cancer (I-CONIC)
A study testing Imatinib 400 MG Oral Tablet in people with Breast Cancer and Triple Negative Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer
- What is being tested?
- Imatinib 400 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2023to 28 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmed invasive primary triple negative breast cancer≥15 mm) with any node status.
- Age ≥18 years
- Triple Negative subtype is defined below:
- Hormone receptor status: the invasive tumour shall be ER- and progesterone receptor (PR) -negative [staining present in <10% by immunohistochemistry (IHC)].
- 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
- No previous systemic treatment for TNBC
Show all 21Show fewer
- No concurrent anti-cancer treatment. Treatment with Bisphosphonates may continue.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Normal organ function as defined below:
- absolute white blood cell count ≥1.5 x 109/L
- platelets ≥100 x 109/L
- haemoglobin ≥90g/dL
- total bilirubin ≤1.5 x institutional upper normal limit (UNL)/dL (≤ 3 x UNL for patients with Gilbert´s syndrome)
- ASAT, ALAT, GGT and alkaline phosphatase levels < 1.5 × institutional UNL.
- albumin >2.5mg/dL
- Creatinine < 110 μmol/L
- T3, T4 and TSH (only patients with previous thyroid dysfunction)
- 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.
- Patients must be able to take (swallow) an oral medication.
- Patients must be capable to understand and comply with the protocol and has signed the informed consent.
Who cannot join
- Patients suitable for neoadjuvant treatment.
- 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).
- Known human immunodeficiency virus (HIV) positivity.
- Known active Hepatitis B or Hepatitis C
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Barbro Linderholm
Gothenburg, 41345
Barbro K Linderholm, MD, PhD, +46-31-3420000 ext. 7941, barbro.linderholm@oncology.gu.se
Elisabeth Kapocs, +46-31-3420000 ext. 8678, elisabeth.kapocs@vgregion.se
About this study
Official title: Use of Imatinib to Convert Triple Negative Breast Cancer Into ER-positive Breast Cancer
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.
Read the detailed 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.
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Being tested
- Imatinib 400 MG Oral Tablet
- Keywords
- Conversion of TNBC to Luminal BC
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib 400 MG Oral TabletDrug
Also called No other intervention
One tablet daily 10 days before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Short term Imatinib | Experimental | Imatinib 400 mg x 1 for 10 days before surgery. Receives: Drug: Imatinib 400 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the proportion of patients that convert to ER expressing breast cancer
ER expression is determined by immunohistochemistry
Measured: From surgery of the first patient to up to 100 weeks thereafter.
Secondary outcomes (1)
Adverse events
AEs are registered according to National Cancer Institute (NCI) CTCAE version 5.0.
Measured: From time of the first included patient to up to 100 weeks thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Jun 2023
- Primary completion28 Jun 2029 (estimated)
- Study completion28 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Window-of-opportunity trial.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Sahlgrenska University Hospital, Lund University
- Responsible party
- Sponsor
- Investigators
- Barbro K Linderholm, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722795
- Sponsor's protocol ID
- EudraCT 2020-005200-19
- Acronym
- I-CONIC
- Status last verified
- Jul 2025
- First submitted
- 11 Apr 2022
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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, Moch H, Scott AM, Eriksson U, Pietras K. Microenvironmental control of breast cancer subtype elicited through paracrine platelet-derived growth factor-CC signaling. Nat Med. 2018 May;24(4):463-473. doi: 10.1038/nm.4494. Epub 2018 Mar 12.
PubMed 29529015Jansson 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/s10549-018-4664-7. Epub 2018 Jan 29.
PubMed 29380207Arnedos 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.
PubMed 31464762
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Imatinib to Convert Triple Negative Breast Cancer Into ER-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT05722795
- Acronym / sponsor ID
- I-CONIC / EudraCT 2020-005200-19
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Keywords
- Conversion of TNBC to Luminal BC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Sahlgrenska University Hospital, Lund University
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 28 Jun 2029 (estimated)
- Study completion
- 28 Dec 2029 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Window-of-opportunity trial.
| Arm | Type | Receives |
|---|---|---|
| Short term Imatinib | Experimental | Drug: Imatinib 400 MG Oral TabletImatinib 400 mg x 1 for 10 days before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histological confirmed invasive primary triple negative breast cancer≥15 mm) with any node status.
- Age ≥18 years
- No previous systemic treatment for TNBC
- No concurrent anti-cancer treatment. Treatment with Bisphosphonates may continue.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Key exclusion criteria (8 listed)
- Patients suitable for neoadjuvant treatment.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imatinib 400 MG Oral TabletAlso: No other interventionOne tablet daily 10 days before surgery. | Drug | Short term Imatinib |
Primary outcome
To determine the proportion of patients that convert to ER expressing breast cancer
Time frame: From surgery of the first patient to up to 100 weeks thereafter.
ER expression is determined by immunohistochemistry
1 secondary outcome
Adverse events
Time frame: From time of the first included patient to up to 100 weeks thereafter.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Results publication: PubMed 29529015Roswall 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, Moch H, Scott AM, Eriksson U, Pietras K. Microenvironmental control of breast cancer subtype elicited through paracrine platelet-derived growth factor-CC signaling. Nat Med. 2018 May;24(4):463-473. doi: 10.1038/nm.4494. Epub 2018 Mar 12.
- Results publication: PubMed 29380207Jansson 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/s10549-018-4664-7. Epub 2018 Jan 29.
- Results publication: PubMed 31464762Arnedos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbro K Linderholm, MD, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imatinib 400 MG Oral Tablet in people with Breast Cancer and Triple Negative Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbro K Linderholm, MD, PhD (+46706045422, barbro.linderholm@oncology.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the proportion of patients that convert to ER expressing breast cancer (time frame: From surgery of the first patient to up to 100 weeks thereafter.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05722795, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.