Imipramine on ER+ve and Triple Negative Breast Cancer

  • STATUS
    Recruiting
  • End date
    Dec 14, 2021
  • participants needed
    24
  • sponsor
    The University of Texas Health Science Center at San Antonio
Updated on 14 March 2021
carcinoma
lobular carcinoma
triple negative breast cancer
ductal carcinoma
core needle biopsy

Summary

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

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.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Imipramine
Clinical Study IdentifierNCT03122444
SponsorThe University of Texas Health Science Center at San Antonio
Last Modified on14 March 2021

Eligibility

Yes No Not Sure

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 (-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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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