Nebivolol to protect the heart during trastuzumab treatment for HER2‑positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.