Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT01009918
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2009-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab
Sponsor:
University of South Florida
Organization:
Study Overview
Official Title:
Phase II Placebo-controlled Trial of Lisinopril and Coreg CR® to Reduce Cardiotoxicity in Patients With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy With Trastuzumab (Herceptin®)
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Lisinopril or Coreg CR®, may help reduce side effects caused by trastuzumab. It is not yet known whether lisinopril or Coreg CR® are more effective than a placebo in reducing side effects caused by trastuzumab.
PURPOSE: This phase II trial is studying lisinopril and Coreg CR® to see how well they work compared with a placebo in reducing side effects in patients with HER2-positive breast cancer receiving trastuzumab.
PURPOSE: This phase II trial is studying lisinopril and Coreg CR® to see how well they work compared with a placebo in reducing side effects in patients with HER2-positive breast cancer receiving trastuzumab.
Detailed Description:
OBJECTIVES:
Primary
* The primary objective of this study is to determine if administration of lisinopril or Coreg CR®, compared to placebo, will reduce the incidence of trastuzumab-induced cardiotoxicity, as measured by LVEF, in patients receiving adjuvant, or neoadjuvant,therapy for HER2 positive breast cancer.
Secondary
* To determine whether subjects randomized to active agent have fewer interruptions in trastuzumab therapy due to cardiomyopathy.
* To determine whether the treatment effect is consistent in anthracycline and nonanthracycline patient cohorts
* To compare changes in HRQL among the treatment groups during the study intervention
* To evaluate the long term effects on the prevention of cardiomyopathy and impact on HRQL for either or both study agents
* To compare the predictive value of troponin I and BNP in the identification of trastuzumab-induced cardiotoxicity
OUTLINE: This is a multicenter study. Patients are stratified according to chemotherapy comprising an anthracycline (yes vs no). Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive oral lisinopril once daily.
* Arm II: Patients receive oral Coreg CR® once daily.
* Arm III: Patients receive oral placebo once daily.
In all arms, study treatment begins with the first dose of trastuzumab and continues for up to 52 weeks or until the end of trastuzumab therapy.
Quality of life is assessed using the EORTC QLQ-C30 questionnaire at baseline, at 52 weeks (or at the end of trastuzumab therapy), and at 18 and 24 months (or 6 and 12 months after the completion of trastuzumab).
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.
Primary
* The primary objective of this study is to determine if administration of lisinopril or Coreg CR®, compared to placebo, will reduce the incidence of trastuzumab-induced cardiotoxicity, as measured by LVEF, in patients receiving adjuvant, or neoadjuvant,therapy for HER2 positive breast cancer.
Secondary
* To determine whether subjects randomized to active agent have fewer interruptions in trastuzumab therapy due to cardiomyopathy.
* To determine whether the treatment effect is consistent in anthracycline and nonanthracycline patient cohorts
* To compare changes in HRQL among the treatment groups during the study intervention
* To evaluate the long term effects on the prevention of cardiomyopathy and impact on HRQL for either or both study agents
* To compare the predictive value of troponin I and BNP in the identification of trastuzumab-induced cardiotoxicity
OUTLINE: This is a multicenter study. Patients are stratified according to chemotherapy comprising an anthracycline (yes vs no). Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive oral lisinopril once daily.
* Arm II: Patients receive oral Coreg CR® once daily.
* Arm III: Patients receive oral placebo once daily.
In all arms, study treatment begins with the first dose of trastuzumab and continues for up to 52 weeks or until the end of trastuzumab therapy.
Quality of life is assessed using the EORTC QLQ-C30 questionnaire at baseline, at 52 weeks (or at the end of trastuzumab therapy), and at 18 and 24 months (or 6 and 12 months after the completion of trastuzumab).
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SCUSF-0806 | OTHER | SunCoast CCOP Research Base | View | |
| 5U10CA081920-11 | NIH | None | https://reporter.nih.gov/quic… | View |