drugset
drugset / Trial / NCT01446159

Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer

NCT01446159 ↗

Phase 2 Completed 188 enrolled MedImmune LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.

Timeline

Start
2011-06-13
Primary completion
2019-06-28
Completion
2019-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject DUSIGITUMAB Monoclonal antibody 10 mg/kg Intravenous
Subject DUSIGITUMAB Monoclonal antibody 30 mg/kg Intravenous
Subject DUSIGITUMAB Monoclonal antibody 45 mg/kg Intravenous
Background Anastrozole Other / unclassified — Oral
Background Exemestane Small molecule — Oral
Background Letrozole Other / unclassified — Oral

Indications

Her2-receptor negative breast cancer