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Lay Description

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

Category

  • Cancers and Other Neoplasms
IRB Number
20170203HU
NCT Number
NCT03122444
Open to Enrollment
Yes

Eligibility

Eligible Ages
Between 18 Years and 71 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Arm Groups

Study Contact


Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Point of Contact
Regulatory Staff
regaffstaff@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Marisa Rodriguez
(210) 450-5976
rodriguezm21@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu

Principal Investigator
Virginia Kaklamani