Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab
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|ClinicalTrials.gov Identifier: NCT01009918|
Recruitment Status : Active, not recruiting
First Posted : November 9, 2009
Last Update Posted : September 19, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Cardiac Toxicity||Drug: Coreg CR® Drug: lisinopril Other: placebo||Phase 2|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||468 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|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®)|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||July 2017|
U.S. FDA Resources
Experimental: Arm I lisinopril
Patients receive oral lisinopril once daily.
Other Name: Registered Trade names: Prinivil, Tensopril, Zestril, Hipril
Experimental: Arm II Coreg CR®
Patients receive oral Coreg CR® once daily.
Drug: Coreg CR®
Other Name: carvedilol phosphate extended-release
Placebo Comparator: Arm III placebo
Patients receive oral placebo once daily.
- Reduction in incidence of trastuzumab-induced cardiotoxicity after 52 weeks of treatment as measured by preservation of LVEF [ Time Frame: 2 years ]
- Comparison of the LVEF of each treatment group with the placebo arm [ Time Frame: 2 years ]
- Number of trastuzumab courses completed without interruption [ Time Frame: 2 years ]
- Quality-of-life changes as assessed by EORTC-QLQ-C30 questionnaire at baseline and at the end of treatment [ Time Frame: 2 years ]
- Long-term effects of study drugs as assessed at 18 and 24 months (or 6 and 12 months after completion of trastuzumab therapy) [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009918
Show 174 Study Locations
|Study Chair:||Maya Guglin, MD, PhD||University of South Florida|
|Study Chair:||Pamela N. Munster, MD||University of California, San Francisco|