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Imipramine on ER+ve and Triple Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03122444
Recruitment Status : Active, not recruiting
First Posted : April 20, 2017
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
Virginia G. Kaklamani, The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE April 17, 2017
First Posted Date  ICMJE April 20, 2017
Last Update Posted Date September 13, 2022
Actual Study Start Date  ICMJE July 5, 2019
Actual Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
Decrease in the proliferation rate of triple negative breast cancer [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imipramine on ER+ve and Triple Negative Breast Cancer
Official Title  ICMJE A Pre-Surgical Window of Opportunity Trial Investigating the Effect of Imipramine on Previously Untreated Breast Cancer (CTMS# 17-0037)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: Imipramine
Imipramine will be given daily for 21-30 days.
Study Arms  ICMJE Experimental: Imipramine
Imipramine will initially be 50mg and this will be increased by 50mg every other day as tolerated to 200 mg.
Intervention: Drug: Imipramine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 10, 2022)
17
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2017)
24
Estimated Study Completion Date  ICMJE March 2023
Actual Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 71 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03122444
Other Study ID Numbers  ICMJE CTMS 17-0037
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Virginia G. Kaklamani, The University of Texas Health Science Center at San Antonio
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Virginia G Kaklamani, MD Principal Investigator
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP