NCT05722795

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
44mo left

Started Jun 2023

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Jun 2023Dec 2029

First Submitted

Initial submission to the registry

April 11, 2022

Completed
10 months until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2029

Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

6.1 years

First QC Date

April 11, 2022

Last Update Submit

July 3, 2025

Conditions

Breast CancerTriple Negative Breast Cancer

Keywords

Conversion of TNBC to Luminal BC

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Adverse events

    From time of the first included patient to up to 100 weeks thereafter.

Other Outcomes (2)

  • Exploratory analyses - gene expression profiles

    From surgery of the first patient to up to 100 weeks thereafter.

  • Exploratory analyses - gene expression profiles

    From time of the first included patient to up to 100 weeks thereafter.

Study Arms (1)

Short term Imatinib

EXPERIMENTAL

Imatinib 400 mg x 1 for 10 days before surgery.

Drug: Imatinib 400 MG Oral Tablet

Interventions

Imatinib 400 MG Oral TabletDRUG

One tablet daily 10 days before surgery.

Also known as: No other intervention
Short term Imatinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +6 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbro Linderholm

Gothenburg, 41345, Sweden

RECRUITING

Related Publications (3)

  • 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.

    PMID: 29529015RESULT

  • 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.

    PMID: 29380207RESULT

  • 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.

    PMID: 31464762RESULT

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Interventions

Imatinib MesylateTablets

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesDosage FormsPharmaceutical Preparations

Study Officials

  • Barbro K Linderholm, MD, PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbro K Linderholm, MD, PhD

CONTACT

+46706045422barbro.linderholm@oncology.gu.se

Elisabeth Kapocs

CONTACT

+46-31-3420000elisabeth.kapocs@vgregion.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Window-of-opportunity trial.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2022

First Posted

February 10, 2023

Study Start

June 1, 2023

Primary Completion (Estimated)

June 28, 2029

Study Completion (Estimated)

December 28, 2029

Last Updated

July 9, 2025

Record last verified: 2025-07

Locations

SE(1)