Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
| Lund University | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short term Imatinib | Experimental | Imatinib 400 mg x 1 for 10 days before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib 400 MG Oral Tablet | Drug | One tablet daily 10 days before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the proportion of patients that convert to ER expressing breast cancer | ER expression is determined by immunohistochemistry | From surgery of the first patient to up to 100 weeks thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | AEs are registered according to National Cancer Institute (NCI) CTCAE version 5.0. | From time of the first included patient to up to 100 weeks thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory analyses - gene expression profiles | Gene expression profiles in tissue - biopsy and surgical specimen. | From surgery of the first patient to up to 100 weeks thereafter. |
| Exploratory analyses - gene expression profiles |
Inclusion Criteria:
Histological confirmed invasive primary triple negative breast cancer≥15 mm) with any node status.
Age ≥18 years
Triple Negative subtype is defined below:
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
Normal organ function as defined below:
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbro K Linderholm, MD, PhD | Contact | +46706045422 | barbro.linderholm@oncology.gu.se | |
| Elisabeth Kapocs | Contact | +46-31-3420000 | 8678 | elisabeth.kapocs@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Barbro K Linderholm, MD, PhD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbro Linderholm | Recruiting | Gothenburg | 41345 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29529015 | Result | 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. | |
| 29380207 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
Not provided
Not provided
Window-of-opportunity trial.
Not provided
Not provided
Not provided
Not provided
Gene expression profiles determined in circulating tumour-DNA
| From time of the first included patient to up to 100 weeks thereafter. |
| Result |
| Jansson 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. |
| 31464762 | Result | Arnedos 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |