NCT02689921

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

A Phase II Study of NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab (NEOADAPT)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Midwestern Regional Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Exemestane	Aromatase inhibitor
DRUG	Letrozole	Aromatase inhibitor
DRUG	Anastrozole	Aromatase inhibitor
DRUG	Leuprolide Acetate	Luteinizing Hormone-Releasing Hormone agonist
DRUG	Pertuzumab	Monoclonal antibody (HER2/neu receptor antagonist)
DRUG	Trastuzumab	Monoclonal antibody (HER2/neu receptor antagonist)

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-02-24
• Last updated: 2018-09-28

Locations

2 sites across 1 country: United States