drugset / Trial / NCT02213042

Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer

NCT02213042 ↗

Phase 2 Terminated 42 enrolled Novartis Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
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 — —

Indications