Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Trastuzumab

Letrozole

Anastrozole

Neratinib

Antineoplastic Agents, Immunological

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Weeks 1-3\* patients receive either (a) Neratinib, (b) Letrozole or Anastrozole or (c) Neratinib + Letrozole or Anastrozole

Weeks 4-24 patients receive Neratinib + Letrozole or Anastrozole and Trastuzumab

\*Starting drug intervention varies for the first 3 weeks depending on arms: a, b, and c by randomization.

120mg for 7 days; 160mg for 7 days ; 240mg for 7 days. 240 mg (up to a maximum of 24 weeks) orally daily\*.

L: (2.5 mg) OR A: (1 mg) orally daily (up to a maximum of 24 weeks)\*

Letrozole (L) or Anastrozole (A)

All Arms 8mg/kg loading dose followed by 6mg/kg every 3 weeks administered every 3 weeks by IV starting wk 4. Trastuzumab biosimilars may be used per institutional guidelines.

Ruth O'Regan, MD

Kimberly Cameron

Oana Danciu, MD

Lisa Carrozzi, OCN

Kathleen Pratt

Cindy Brown

Monali Vasekar, MD

UW Cancer Connect

Kari Wisinski, MD

Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for 24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast biopsy will be performed prior to Day 1 of week 4 of treatment. Following surgery, patients will receive standard of care HER2-directed and endocrine therapy at the treating physician's discretion.

Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

An Open Label, Phase II Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Cancers Hoosier Cancer Research Network BRE17-141

pCR is defined as the lack of all signs of invasive cancer in the breast removed during surgery

Assess the adverse events of neratinib in combination with NSAI in subjects

Estimate the pCR (ypT0/Tis ypN0) in the breast tissue and lymph nodes

Estimate residual disease in the breast tissue

Puma Biotechnology, Inc.

University of Rochester

Ruth O'Regan

Sponsor Investigator

Spots Global Cancer Trial Database for letrozole (l) or anastrozole (a)