Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 71 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Early Phase 1
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Imipramine
Imipramine will initially be 50mg and this will be increased by 50mg every other day as tolerated to 200 mg.
  • Drug: Imipramine
    Imipramine will be given daily for 21-30 days.

Recruiting Locations

Mays Cancer Center, UT Health San Antonio
San Antonio, Texas 78229
Contact:
Epp Goodwin
210-450-1000

More Details

NCT ID
NCT03122444
Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Epp Goodwin
210-450-5798
ctrcreferral@uthscsa.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.