Clinical trial · Interventional
Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab
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®)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiac Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Coreg CR® | Drug | — | UNRESOLVED |
| lisinopril | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I lisinopril
- description
- Patients receive oral lisinopril once daily.
- interventionNames
- Drug: lisinopril
- type
- EXPERIMENTAL
- label
- Arm II Coreg CR®
- description
- Patients receive oral Coreg CR® once daily.
- interventionNames
- Drug: Coreg CR®
- type
- PLACEBO_COMPARATOR
- label
- Arm III placebo
- description
- Patients receive oral placebo once daily.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGuglin M, Krischer J, Tamura R, Fink A, Bello-Matricaria L, McCaskill-Stevens W, Munster PN. Randomized Trial of Lisinopril Versus Carvedilol to Prevent Trastuzumab Cardiotoxicity in Patients With Breast Cancer. J Am Coll Cardiol. 2019 Jun 11;73(22):2859-2868. doi: 10.1016/j.jacc.2019.03.495. PMID 31171092