Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in Triple Positive Breast Cancers

Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in Triple Positive Breast Cancers
Experimental: A

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.

Drug: Neratinib

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

Other Name: Nerlynx

Drug: Letrozole (L) or Anastrozole (A)

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

Other Names:

  • Femara
  • Arimidex

Drug: Trastuzumab

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.

Other Name: Herceptin

Source: View full study details on ClinicalTrials.gov

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October 14, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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