US2020054634A1PendingUtilityA1

Endocrine therapy and abemaciclib combination for the adjuvant treatment of node-positive, early stage, hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer

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Assignee: LILLY CO ELIPriority: May 2, 2017Filed: Apr 25, 2018Published: Feb 20, 2020
Est. expiryMay 2, 2037(~10.8 yrs left)· nominal 20-yr term from priority
Inventors:Ian C. Smith
A61K 31/5685A61K 31/506A61K 31/4196A61K 31/138A61P 35/04
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Claims

Abstract

The present invention discloses an adjuvant treatment of node-positive, early stage, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer comprising administering an effective amount of an endocrine therapy in combination with an effective amount of abemaciclib or a pharmaceutically acceptable salt thereof.

Claims

exact text as granted — not AI-modified
1 . A method of providing adjuvant treatment to a patient with a prior diagnosis of node-positive, early stage, HR+, HER2− breast cancer which has been resected comprising administering an effective amount of an endocrine therapy in combination with an effective amount of abemaciclib or a pharmaceutically acceptable salt thereof for a time period sufficient to increase distant relapse-free survival. 
     
     
         2 . The method according to  claim 1  wherein the endocrine therapy is tamoxifen or a pharmaceutically acceptable salt thereof. 
     
     
         3 . The method according to  claim 1  wherein the endocrine therapy is letrozole. 
     
     
         4 . The method according to  claim 1  wherein the endocrine therapy is anastrozole. 
     
     
         5 . The method according to  claim 1  wherein the endocrine therapy is exemestane. 
     
     
         6 . The method according to  claim 1  wherein the abemaciclib or the salt thereof is administered at 150 mg twice daily. 
     
     
         7 . The method according to  claim 1  wherein the abemaciclib or the salt thereof is administered at 100 mg twice daily. 
     
     
         8 - 16 . (canceled) 
     
     
         17 . The method according to  claim 2  wherein the abemaciclib or the salt thereof is administered at 150 mg twice daily. 
     
     
         18 . The method according to  claim 2  wherein the abemaciclib or the salt thereof is administered at 100 mg twice daily. 
     
     
         19 . The method according to  claim 3  wherein the abemaciclib or the salt thereof is administered at 150 mg twice daily. 
     
     
         20 . The method according to  claim 3  wherein the abemaciclib or the salt thereof is administered at 100 mg twice daily. 
     
     
         21 . The method according to  claim 4  wherein the abemaciclib or the salt thereof is administered at 150 mg twice daily. 
     
     
         22 . The method according to  claim 4  wherein the abemaciclib or the salt thereof is administered at 100 mg twice daily. 
     
     
         23 . The method according to  claim 5  wherein the abemaciclib or the salt thereof is administered at 150 mg twice daily. 
     
     
         24 . The method according to  claim 5  wherein the abemaciclib or the salt thereof is administered at 100 mg twice daily.

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