Phase 3
Completed N=207
A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00022672 ↗Enrolled (actual)
207
Serious AEs
14.7%
Results posted
Jun 2013
Primary outcomePrimary: Progression Free Survival (PFS) — 4.8; 2.4; 5.8; 2.9 Months
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
4.8; 2.4; 5.8; 2.9 | — |
| SECONDARY Percentage of Participants With Clinical Benefit |
42.7; 27.9; 45.6; 30.8 | — |
| SECONDARY Duration of Response at 24 Months |
9.5; 10.0 | — |
| SECONDARY Time to Response at 24 Months |
2.0; 2.0 | — |
| SECONDARY Overall Survival at 24 Months |
28.5; 23.9 | — |
| SECONDARY Percentage of Participants With Two-Year Survival |
52.4; 45.2 | — |
| SECONDARY Percentage of Participants With Overall Tumor Response at 24 Months |
20.3; 6.8 | — |
| SECONDARY Percentage of Participants With Best Tumor Response at 24 Months |
0.0; 0.0; 20.3; 6.8; 37.8; 38.4 | — |
| SECONDARY Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Final Visit Compared to Baseline |
10.3; 4.1; 67.6; 64.4; 22.1; 31.5 | — |
| SECONDARY Duration of Response at End of Study |
12.3; 8.2 | — |
| SECONDARY Time to Response at End of Study |
2.4; 2.1 | — |
| SECONDARY Percentage of Participants With Overall Tumor Response at End of Study |
22.3; 8.7 | — |
| SECONDARY Percentage of Participants With Best Tumor Response at End of Study |
1.0; 3.8; 21.4; 4.8; 47.6; 40.4 | — |
| SECONDARY Number of Participants With Adverse Events |
90; 68 | — |
Eligibility Criteria
Inclusion Criteria
- postmenopausal women;
- metastatic breast cancer suitable for endocrine therapy;
- positive hormone receptor status;
- Human epidermal growth factor receptor 2 (HER2) overexpression.
Exclusion Criteria
- patients on hormone replacement therapy;
- previous chemotherapy for metastatic disease;
- uncontrolled cardiac disease and history of cardiac failure.
Data sourced from ClinicalTrials.gov (NCT00022672). 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.