At a glance
ClinicalIndex Comparison Record- ✓Postmenopausal women
- ✓Metastatic breast cancer suitable for endocrine therapy
- ✓Positive hormone receptor status
- ✓HER2 overexpression
- ✕On hormone replacement therapy
- ✕Prior chemotherapy for metastatic disease
- ✕Uncontrolled cardiac disease or history of cardiac failure
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-label Study of the Effect of Herceptin Plus Arimidex Compared With Arimidex Alone on Progression-free Survival in Patients With HER2-positive and Hormone-receptor Positive Metastatic Breast Cancer
In Brief
A Phase 3 clinical trial evaluating trastuzumab (Herceptin®) and anastrazole (Arimidex®) for Breast Cancer. Completed, enrolled 208 participants across 132 sites in 26 countries.
Detailed Summary
This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.
Study Details
Timeline
Interventions
4mg/kg iv loading dose, followed by 2mg/kg iv weekly
1 mg tablet taken orally daily