Methods of treating her2-positive metastatic breast cancer

Abstract

Methods of treating patients having HER2-positive, locally advanced or previously untreated metastatic breast cancer having received prior treatment with a taxane using an anti-HER2-maytansinoid conjugate (for example trastuzumab emtansine) are provided.

We claim: 
     
         1 . A method of treating HER2-positive locally advanced or metastatic breast cancer in a patient, the method comprising:
 (1) determining that the patient has received prior treatment of a locally non-advanced and non-metastatic HER2-positive breast cancer with a taxane prior to progression to positive locally advanced or metastatic disease and the last prior dose of the taxane treatment was at least ≥6 months before administration of an anti-HER2-maytansinoid conjugate, and   (2) administering to the patient having the HER2-positive locally advanced or metastatic breast cancer a therapeutically effective amount of the anti-HER2-maytansinoid conjugate,   wherein after the patient's cancer progressed to HER2-positive locally advanced or metastatic disease but prior to treatment with the anti-HER2-maytansinoid conjugate, the patient has not been treated with any chemotherapy.   
     
     
         2 . The method of  claim 1 , wherein the patient received prior treatment with a taxane and at least one HER2-directed therapy. 
     
     
         3 . The method of  claim 2 , wherein the patient received prior treatment with a taxane and trastuzumab. 
     
     
         4 . The method of  claim 3 , wherein the patient received prior treatment with a taxane, trastuzumab, and pertuzumab. 
     
     
         5 . The method of  claim 1 , wherein the prior treatment was administered in the adjuvant setting. 
     
     
         6 . The method of  claim 1 , wherein the prior treatment was administered in the neoadjuvant setting. 
     
     
         7 . The method of  claim 1 , wherein the taxane is paclitaxel. 
     
     
         8 . The method of  claim 7 , wherein the paclitaxel was administered at 80 mg/m 2  intravenously weekly. 
     
     
         9 . The method of  claim 8 , wherein the paclitaxel was administered for a minimum of 18 weeks. 
     
     
         10 . The method of  claim 1 , wherein the taxane is docetaxel. 
     
     
         11 . The method of  claim 10 , wherein the docetaxel was administered at 75 mg/m 2  or 100 mg/m 2  intravenously every 3 weeks. 
     
     
         12 . The method of  claim 11 , wherein the docetaxel was administered for a minimum of 6 cycles. 
     
     
         13 . The method of  claim 3 , wherein the trastuzumab was administered at 8 mg/kg intravenously on cycle 1 followed by 6 mg/kg every 3 weeks in subsequent cycles. 
     
     
         14 . The method of  claim 3 , wherein the trastuzumab was administered at 4 mg/kg intravenously on day 1 of cycle 1 followed by 2 mg/kg weekly starting on day 8 of cycle 1. 
     
     
         15 . The method of  claim 4 , wherein the pertuzumab was administered at 840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles. 
     
     
         16 . The method of  claim 1 , wherein the anti-HER2-maytansinoid conjugate is a trastuzumab-maytansinoid conjugate. 
     
     
         17 . The method of  claim 16 , wherein the trastuzumab-maytansinoid conjugate is a trastuzumab-DM1 conjugate. 
     
     
         18 . The method of  claim 17 , wherein the trastuzumab-DM1 conjugate is trastuzumab-MCC-DM1. 
     
     
         19 . The method of  claim 18 , wherein the trastuzumab-MCC-DM1 is administered every three weeks at 3.6 mg/kg. 
     
     
         20 . The method of  claim 18 , wherein the trastuzumab-MCC-DM1 is administered every week at 2.4 mg/kg.