Clinical Trials /

Imipramine on Triple Negative Breast Cancer

NCT03122444

Description:

Comparing changes in biomarkers from a diagnostic core needle biopsy to surgical pathology specimen or repeat core needle biopsy.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Imipramine on Triple Negative Breast Cancer
  • Official Title: A Pre-Surgical Window of Opportunity Trial Investigating the Effect of Imipramine on Triple Negative Breast Cancer (CTMS# 17-0037)

Clinical Trial IDs

  • ORG STUDY ID: CTMS 17-0037
  • NCT ID: NCT03122444

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
ImipramineImipramine

Purpose

Comparing changes in biomarkers from a diagnostic core needle biopsy to surgical pathology specimen or repeat core needle biopsy.

Detailed Description

      This will be a single arm, non-randomized, pre-surgical clinical trial of women with newly
      diagnosed triple negative breast cancer comparing changes in biomarkers from a diagnostic
      core needle biopsy to surgical pathology specimen or repeat core needle biopsy.
    

Trial Arms

NameTypeDescriptionInterventions
ImipramineExperimentalImipramine will initially be 50mg and this will be increased by 50mg every other day as tolerated to 200 mg.
  • Imipramine

Eligibility Criteria

        Inclusion Criteria:

          -  Participants may be female or male who are 18 years old or older.

          -  Ability to consent to treatment - patients or their legally authorized representative
             must be informed of the investigational nature of this study and must sign and give
             written informed consent in accordance with institutional and federal guidelines.

          -  Previously untreated breast cancer determined by a core needle biopsy showing invasive
             ductal carcinoma or invasive lobular carcinoma.

          -  A prior, unrelated, breast cancer is allowed.

          -  All stages of breast cancer are eligible.

          -  Estrogen receptor negative - defined as less than 1% staining by IHC.

          -  Progesterone receptor negative - defined as less than 1% staining by IHC.

          -  HER2 negative defined as 0 or 1+ using IHC or a ratio of less than 2.0 on FISH
             testing. HER2 of 2+ on IHC should have a ratio of less than 2.0 on FISH testing to be
             considered HER2 negative.

          -  Patient must be able to take oral medications. Patients may not have any impairment of
             gastrointestinal function or gastrointestinal disease that may significantly alter the
             absorption of the study drug.

          -  Females of childbearing potential must have a negative serum or urine beta human
             chorionic gonadotropin (β-hCG) pregnancy test result within 14 days prior to the first
             dose of imipramine.

          -  Patients must be eligible for surgical resection of their breast cancer or repeat
             biopsy after completing treatment.

          -  Patients must have a complete history and physical examination within 30 days prior to
             registration.

          -  Patients must have a performance status of ECOG 0, 1, 2.

          -  Tissue block of initial biopsy specimen is available.

          -  Patient may not be concurrently enrolled in another investigational drug treatment
             study.

        Exclusion Criteria:

          -  Known diagnosis of major depressive disorder, bipolar depression or psychosis

          -  ECOG 3 or 4

          -  Age >= 70 years

          -  Renal impairment defined as EGFR <30

          -  Hepatic impairment as judged by clinical investigator or bilirubin >2

          -  As judged by the investigator, severe uncontrolled concurrent medical conditions,
             psychiatric illness or social condition that would limit compliance with study
             requirements

          -  History of cardiac disease (arrhythmia, conduction abnormality, congenital prolonged
             QT syndrome, or prolonged QTc rhythm noted during initial EKG >480 ms)

          -  Current use of SSRI, SNRI, MAO inhibitor, tramadol or trazadone; or use of these
             agents within 14 days

          -  Inflammatory breast cancer

          -  Suicidal ideation or history of suicide attempt

          -  Myocardial infarction within 3 months of study initiation.

          -  Patients with Angle-Closure Glaucoma

          -  Pregnant or breast-feeding women. As there have been no well-controlled studies
             conducted with pregnant women to determine the effect of imipramine on the fetus.
             However, there have been clinical reports of congenital malformations associated with
             the use of the drug.
      
Maximum Eligible Age:71 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Decrease in the proliferation rate of triple negative breast cancer
Time Frame:30 days
Safety Issue:
Description:

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:The University of Texas Health Science Center at San Antonio

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