OBJECTIVE: A Phase 1 trial was conducted in @entity1 with @entity172 negative receptors (ER) or hormone refractory metastatic @entity0 to determine the maximum tolerated dose (MTD) of @entity1260 with a fixed dose of @entity632 . A secondary objective was to determine the efficacy of the combination in metastatic @entity0 . METHODS: Fifteen @entity1 were entered in the study in cohorts of three @entity1 at each dose level of @entity1260 . The dose of @entity632 was fixed at 45 mg/m2. Five different dose levels of @entity1260 were tested ranging from dose level 1 of 1.5 gms/m2 day 1-3 to level V at 2.5 gms/m2 day 1-3. RESULTS: Dose escalation of @entity1260 was stopped at 2.5 gms/m2. The MTD of @entity1260 was 2.25 gms/m2 day 1-3 in combination with @entity632 . All @entity1 in the study were assessable for @entity137 . @entity1398 and @entity882 were the major dose limiting @entity137 . Other @entity137 included @entity417 , @entity911 and @entity811 . Objective responses were documented in 11 of 15 @entity1 (73.3%). Median time to treatment failure (TTF) was 13 months. Median overall survival (OS) was 18 months. CONCLUSION: The combination of @entity1260 and @entity632 was a practical well tolerated regimen. There was substantial evidence of clinical activity in this phase I trial. This combination should be further evaluated, as an attractive alternative to @entity6023 for @entity1 in developing countries where cost effectiveness is important.

Phase 1 trial of @entity1260 and XXXX in metastatic @entity0 .

@entity1 :: ('9606', 'Species') :: ['patients'] @entity632 :: ('MESH:D004317', 'Chemical') :: ['doxorubicin'] @entity172 :: ('MESH:D004967', 'Chemical') :: ['estrogen'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity6023 :: ('MESH:D043823', 'Chemical') :: ['taxanes'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancer'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity417 :: ('MESH:D000740', 'Disease') :: ['anemia'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['Neutropenia'] @entity911 :: ('MESH:D003221', 'Disease') :: ['confusion'] @entity1260 :: ('MESH:D007069', 'Chemical') :: ['ifosfamide'] @entity811 :: ('MESH:D006417', 'Disease') :: ['hematuria']
@entity632 :: (MESH:D004317,Chemical) :: ['adriamycin']
