drugset / Trial / NCT02689921

NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer

NCT02689921

Phase 2 Unknown 7 enrolled Midwestern Regional Medical Center
NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, single-arm, phase II study of 32 evaluable patients treated with NEOADjuvant Aromatase inhibitor and Pertuzumab/Trastuzumab (NEOADAPT) without chemotherapy for hormone receptor positive (HR+), \[i.e. Estrogen Receptor positive (ER+) and/or Progesterone Receptor positive (PR+)\] HER2+ localized, non-metastatic stage I - IIb breast cancer.

Timeline

Start
2016-04
Primary completion
2018-12
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Anastrozole Other / unclassified 1 mg Oral
Subject Exemestane Small molecule 25 mg Oral
Subject Letrozole Other / unclassified 2.5 mg Oral
Subject Leuprolide Other / unclassified 11.25 mg Intramuscular
Subject Pertuzumab Monoclonal antibody 420 mg Intravenous
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous

Indications