Imipramine on ER+ve and Triple Negative Breast Cancer

A Pre-Surgical Window of Opportunity Trial Investigating the Effect of Imipramine on Previously Untreated Breast Cancer (CTMS# 17-0037)

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Imipramine

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Mays Cancer Center, UT Health San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 breast cancers with possibility for surgical excision will be included.
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease in the proliferation rate of triple negative breast cancer	30 days

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Virginia G Kaklamani, MD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2019
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 20, 2017

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Tricyclic; Adrenergic Uptake Inhibitors; Imipramine
• Other Study ID Numbers: CTMS 17-0037

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No