drugset / Trial / NCT02213042
Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This was a multicenter, open-label, Phase II study in subjects with Human epidermal growth factor receptor (HER2)-positive metastatic breast cancer who received at least 2 prior lines of anti-HER2-targeted therapies of which at least one included a Trastuzumab-containing regimen. This study was a post-approval commitment with regulatory authorities. It was designed to evaluate whether treatment with Dual blockade promoted changes to biomarkers associated with immunomodulation.
Timeline
- Start
- 2014-10-24
- Primary completion
- 2020-06-04
- Completion
- 2020-06-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lapatinib | Small molecule | 1000 mg | Oral |
| Comparator | Trastuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Comparator | Anastrozole | Other / unclassified | — | — |
| Comparator | Exemestane | Small molecule | — | — |
| Comparator | Letrozole | Other / unclassified | — | — |