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
Outcome
Outcome not reported
Stopped: “Primary analysis was completed in 2018 and continued minimal data collection from the one participant active in the study was not expected to add meaningful knowledge to the understanding of lapatinib”
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 | — | — |