Phase 2 Completed N=468 Randomized Double-blind Supportive Care

Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab

Breast Cancer · cardiac toxicity

Source: ClinicalTrials.gov NCT01009918 ↗

Enrolled (actual)

468

Serious AEs

3.2%

Results posted

Mar 2021

Primary outcomePrimary: Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment — 45; 43; 46 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment	45; 43; 46	—
PRIMARY Number of Participants With LVEF Decrease to <50%	5; 9; 15	—
SECONDARY Number of Patients With Trastuzumab Course Interruption	27; 24; 40	—
SECONDARY Quality-of-life Changes Between Baseline and 52-weeks	1; 2; 5	—
SECONDARY Number of Participants With Cardiotoxicity-free Survival at 750 Days From Baseline	15; 24; 17	—

Eligibility Criteria

INCLUSION CRITERIA

Males and Females ≥ 18 years old diagnosed with HER2 positive breast cancer
Scheduled to receive neoadjuvant or adjuvant trastuzumab (Herceptin®) therapy (anthracycline-containing regimens are permitted). Patients receiving Herceptin® with their chemotherapy are permitted for eligibility work-up. Taxanes are permitted. Trastuzumab (Herceptin®) therapy may be given with or after primary chemotherapy. Pertuzumab may be used in conjunction with trastuzumab.
Left Ventricular Ejection Fraction (LVEF) ≥ 50% by MUGA scan or echocardiogram
Adequate renal function for administration of trastuzumab-containing chemotherapy regimen.
Sitting systolic blood pressure of > 90 mm Hg
Pulse ≥ 60 beats/minute
Not pregnant or breastfeeding
Female patients of childbearing potential, who are sexually active, must have a negative pregnancy test before starting the study
Both men and women must be willing to use effective contraception during the study. Teratogenicity is documented for both active study agents
Able to swallow capsules

EXCLUSION CRITERIA

Patients with metastatic disease
Prior treatment with trastuzumab or anthracyclines prior to this chemotherapy regimen
Current treatment with angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), such as losartan, β-blockers or digoxin
Known cardiac history: heart failure, myocardial infarction, radiation-induced cardiac dysfunction
Known allergy to either ACE inhibitors or β-blockers
History of bronchial asthma or related bronchospastic conditions
Hereditary or idiopathic angioedema
History of severe hypersensitivity reactions to drugs or other causes, i.e. bee stings
This protocol does not exclude patients who are participating on other investigational studies. Refer to the local IRB guidelines.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01009918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.