Clinical trial NCT03122444: Imipramine on ER+ve and Triple Negative Breast Cancer
Official title: A Pre-Surgical Window of Opportunity Trial Investigating the Effect of Imipramine on Previously Untreated Breast Cancer (CTMS# 17-0037)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Decrease in the proliferation rate of triple negative breast cancer
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Mays Cancer Center, UT Health San Antonio
state: Texas
Study officials:
affiliation: Principal Investigator
name: Virginia G Kaklamani, MD
role: PRINCIPAL_INVESTIGATOR
References: