At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 468 enrolled
Drug / intervention
Coreg CR® +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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®)
In Brief
A Phase 2 clinical trial evaluating Coreg CR®, lisinopril, and 1 other intervention for Breast Cancer and Cardiac Toxicity. Completed, enrolled 468 participants across 174 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Cardiac Toxicity
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2009
Enrollment StartMar 2010
Primary CompletionAug 2017
Study CompletionNov 2018
TodayJul 2026
First PostedNov 9, 2009
Enrollment StartMar 1, 2010
Primary CompletionAug 1, 2017
Study CompletionNov 1, 2018
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 16.6 years ago
Interventions
Coreg CR®drug
Given orally
lisinoprildrug
Given orally
placeboother
Given orally