BACKGROUND: We conducted a multiinstitutional phase II study of @entity416 in combination with @entity1206 and trastuzumab in @entity1 eligible to receive first- or second-line treatment for @entity1 epidermal growth factor receptor type 2 ( @entity1722 )-positive ( @entity1722 (+)) @entity0 ( @entity0 ). @entity1 AND METHODS: The study was designed to test that the true confirmed response rate (CRR) was at most 45% vs. a true CRR of at least 65%. Between March 2005 and June 2008, eligible @entity1 received @entity416 825 mg/m   orally on days 1 to 14, @entity1206 25 mg/m   intravenously on days 1 and 8 every 3 weeks, and trastuzumab 8 mg/kg intravenously on day 1 week 1 and 6 mg/kg every 3 weeks. The main outcome measure was CRR. RESULTS: Of 47 @entity1 accrued, 45 were evaluable. This design required at least 25 confirmed responses in the 45 evaluable @entity1 for the treatment to be considered promising. Thirty @entity1 (67%) achieved a confirmed response; 25 @entity1 (56%) had a confirmed partial response (PR); 5 @entity1 (11%) had confirmed complete responses (CRs). Median progression-free survival (PFS) was 11.3 months (95% confidence interval [CI], 8.4-16.7 months). Median overall survival was 28.5 months (95% CI, 24.8-36.4 months). CONCLUSIONS: This triplet combination demonstrated promising activity in @entity1 with @entity1722 (+) @entity0 .

Phase II interventional study (N0337) of XXXX in combination with @entity1206 and trastuzumab for first- or second-line treatment of @entity1722 -positive @entity0 : a north central cancer treatment group trial.

@entity1 :: ('9606', 'Species') :: ['women', 'human', 'patients', 'PATIENTS'] @entity0 :: ('MESH:D001943', 'Disease') :: ['metastatic breast cancer', 'MBC'] @entity416 :: ('MESH:C110904', 'Chemical') :: ['capecitabine'] @entity1206 :: ('MESH:C030852', 'Chemical') :: ['vinorelbine'] @entity1722 :: ('2064', 'Gene') :: ['HER2']
@entity416 :: (MESH:C110904,Chemical) :: ['capecitabine']
