Imipramine on ER+ve and Triple Negative Breast Cancer

NCT03122444 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: CTMS 17-0037
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Decrease in the proliferation rate of triple negative breast cancer

  30 days

Study Arms (1)

Imipramine

EXPERIMENTAL

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

Drug: Imipramine

Interventions

Imipramine DRUG

Imipramine will be given daily for 21-30 days.

Imipramine

Eligibility Criteria

• Age: 18 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Imipramine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Virginia G Kaklamani, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 20, 2017
• Study Start: July 5, 2019
• Primary Completion: March 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

US (1)