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

Primary Purpose

Breast Cancer, Triple Negative Breast Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Imatinib 400 MG Oral Tablet
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Conversion of TNBC to Luminal BC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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 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. Exclusion Criteria: 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

Sites / Locations

  • Barbro Linderholm

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Short term Imatinib

Arm Description

Imatinib 400 mg x 1 for 10 days before surgery.

Outcomes

Primary Outcome Measures

To determine the proportion of patients that convert to ER expressing breast cancer
ER expression is determined by immunohistochemistry

Secondary Outcome Measures

Adverse events
AEs are registered according to National Cancer Institute (NCI) CTCAE version 5.0.

Full Information

First Posted
April 11, 2022
Last Updated
February 1, 2023
Sponsor
Vastra Gotaland Region
Collaborators
Sahlgrenska University Hospital, Sweden, Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT05722795
Brief Title
Use of Imatinib to Convert Triple Negative Breast Cancer Into ER-positive Breast Cancer (I-CONIC)
Acronym
I-CONIC
Official Title
Use of Imatinib to Convert Triple Negative Breast Cancer Into ER-positive Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 6, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region
Collaborators
Sahlgrenska University Hospital, Sweden, Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Triple Negative Breast Cancer
Keywords
Conversion of TNBC to Luminal BC

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Window-of-opportunity trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Short term Imatinib
Arm Type
Experimental
Arm Description
Imatinib 400 mg x 1 for 10 days before surgery.
Intervention Type
Drug
Intervention Name(s)
Imatinib 400 MG Oral Tablet
Other Intervention Name(s)
No other intervention
Intervention Description
One tablet daily 10 days before surgery.
Primary Outcome Measure Information:
Title
To determine the proportion of patients that convert to ER expressing breast cancer
Description
ER expression is determined by immunohistochemistry
Time Frame
From surgery of the first patient to up to 100 weeks thereafter.
Secondary Outcome Measure Information:
Title
Adverse events
Description
AEs are registered according to National Cancer Institute (NCI) CTCAE version 5.0.
Time Frame
From time of the first included patient to up to 100 weeks thereafter.
Other Pre-specified Outcome Measures:
Title
Exploratory analyses - gene expression profiles
Description
Gene expression profiles in tissue - biopsy and surgical specimen.
Time Frame
From surgery of the first patient to up to 100 weeks thereafter.
Title
Exploratory analyses - gene expression profiles
Description
Gene expression profiles determined in circulating tumour-DNA
Time Frame
From time of the first included patient to up to 100 weeks thereafter.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbro K Linderholm, MD, PhD
Phone
+46706045422
Email
barbro.linderholm@oncology.gu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Kapocs
Phone
+46-31-3420000
Ext
8678
Email
elisabeth.kapocs@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbro K Linderholm, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbro Linderholm
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbro K Linderholm, MD, PhD
Phone
+46-31-3420000
Ext
7941
Email
barbro.linderholm@oncology.gu.se
First Name & Middle Initial & Last Name & Degree
Elisabeth Kapocs
Phone
+46-31-3420000
Ext
8678
Email
elisabeth.kapocs@vgregion.se

12. IPD Sharing Statement

Citations:
PubMed Identifier
29529015
Citation
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.
Results Reference
result
PubMed Identifier
29380207
Citation
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.
Results Reference
result
PubMed Identifier
31464762
Citation
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.
Results Reference
result

Learn more about this trial

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

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