Nebivolol to protect the heart during trastuzumab treatment for HER2‑positive breast cancer
Evaluation of the Cardioprotective Effect of Nebivolol on Trastuzumab-Induced Cardiotoxicity in Breast Cancer Patients
This study will test whether taking nebivolol 5 mg can prevent drops in heart function in adults with newly diagnosed early or locally advanced HER2‑positive breast cancer who are starting trastuzumab.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy, doxorubicin |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07233499 on ClinicalTrials.gov |
What this trial studies
Adults (≥18 and ≤65) with newly diagnosed early or locally advanced HER2‑positive breast cancer and a normal baseline LVEF (>50%) will receive nebivolol 5 mg while starting HER2‑directed therapy including trastuzumab. Cardiac function will be followed with echocardiography and clinical exams to detect left ventricular dysfunction or signs of heart failure during treatment. Patients already on ACE inhibitors, ARBs, CCBs, or other beta‑blockers, and those with preexisting cardiomyopathy or ischemic heart disease, are excluded to isolate the effect of nebivolol. The trial aims to determine whether nebivolol reduces trastuzumab‑associated declines in LVEF and symptomatic heart failure.
Who should consider this trial
Good fit: Ideal participants are adults (18–65) with newly diagnosed early or locally advanced HER2‑positive breast cancer, normal baseline LVEF (>50%), not taking ACE inhibitors/ARBs/CCBs or other beta‑blockers, and able to attend echocardiographic monitoring in Cairo.
Not a fit: Patients older than 65, those with existing cardiomyopathy, ischemic heart disease, low baseline LVEF, current use of cardioprotective medications, pregnancy, or hypersensitivity to beta‑blockers are unlikely to benefit.
Why it matters
Potential benefit: If successful, nebivolol could reduce trastuzumab‑related declines in LVEF and lower the risk of heart failure, helping patients stay on effective HER2 therapy.
How similar studies have performed: Previous trials of beta‑blockers or ACE inhibitors for chemotherapy‑related cardiotoxicity have produced mixed results, and nebivolol specifically has limited prior data in trastuzumab cardioprotection.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years old. * Newly diagnosed with early or locally advanced HER2 positive breast cancer. * Normal baseline LVEF (˃50%) * Planned to receive HER2-directed therapies as newadjuvant or adjuvant. Exclusion Criteria: * Elderly patients( ˃65 years). * Primary tumors other than breast cancer. * Pregnancy and breast feeding. * Currently using cardioprotective drugs e.g.: ACEI, CCB, ARBs and another beta blocker. * Presence of diagnosed cardiomyopathy currently or in initial evaluation. * Patients with ischemic heart disease. * Contraindication for treatment with beta blockers. * Patients with hypersensitivity to nebivolol. * Poorly echogenic patients.
Where this trial is running
Cairo
- National Cancer Institute- Cairo University- Egypt — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: May A Shawki, Ph.D
- Email: mayahmed@pharma.asu.edu.eg
- Phone: 01001701461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.