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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Barbro Linderholm
RECRUITING
Gothenburg
Contact Information
Primary
Barbro K Linderholm, MD, PhD
barbro.linderholm@oncology.gu.se
+46706045422
Backup
Elisabeth Kapocs
elisabeth.kapocs@vgregion.se
+46-31-3420000
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2029-12-28
Participants
Target number of participants: 40
Treatments
Experimental: Short term Imatinib
Imatinib 400 mg x 1 for 10 days before surgery.
Sponsors
Leads: Vastra Gotaland Region
Collaborators: Lund University, Sahlgrenska University Hospital

This content was sourced from clinicaltrials.gov