A randomized trial of XXXX , @entity2664 and @entity11887 in @entity0 (a South West Oncology Group Study).

@entity1 @entity632 @entity172 @entity137 @entity390 @entity10517 @entity0 @entity1665 @entity712 @entity2664 @entity391 @entity74 @entity1431 @entity299 @entity11887
New agents with increased activity and/or reduced @entity137 are needed for the treatment of @entity0 . The @entity10517 derivatives @entity2664 and @entity11887 had significant activity and acceptable @entity137 in phase II trials. In an ongoing phase III trial we have now randomized 150 @entity1 with @entity0 to either @entity632 (60 mg/m2), @entity2664 (14 mg/m2) or @entity11887 (260 mg/m2) i.v. q 3 weeks with re-randomization for cross-over at the time of progression to determine the relative efficacy and @entity137 of these three agents. To be eligible, @entity1 must have had only one previous chemotherapy regimen. ER positive @entity1 must have failed endocrine therapy. @entity1 with CHF or severe @entity299 were ineligible. In this preliminary evaluation, 117 @entity1 are evaluable for response and 110 for @entity137 . Median age for all @entity1 is 58 years (range 26-78). The majority (86%) are postmenopausal. Fifty-nine percent percent of the @entity1 have @entity74 . @entity172 receptor is positive in 37%, negative in 39% and unknown in 24% of @entity1 . Median performance status (SWOG) is 1, range 0-2. Objective responses have been observed on each arm ( @entity632 9/35, @entity2664 6/38, @entity11887 6/44). Thirty-two @entity1 are evaluable for cross-over response ( @entity632 2/13, @entity2664 1/11, @entity11887 0/8). The predominant @entity137 is @entity1431 with a nadir WBC count less than 2000 in 45% of all courses administered. @entity1431 is similar with the three drugs. Significant @entity390 , @entity391 and @entity1665 are common with @entity632 and uncommon with the other agents. @entity712 has been observed in one @entity1 ( @entity632 ). Definitive conclusions regarding the efficacy and @entity137 of these agents await the completion of this trial.
