Imipramine on ER+ve and Triple Negative Breast Cancer

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

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Imipramine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 71 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imipramine<br>Imipramine will initially be 50mg and this will be increased by 50mg every other day as tolerated to 200 mg. | Drug: Imipramine<br>* Imipramine will be given daily for 21-30 days.<br>|

What is the study measuring?
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Primary Outcome Measures

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