UNASSIGNED: 1118 Background: Achievement of pathologic complete response (pCR) to preoperative therapy is a predictor of improved disease-free and overall survival. Sequential and concurrent regimens of D and C were evaluated in @entity1 with @entity1722 -negative @entity0 who were candidates for preoperative chemotherapy. METHODS: @entity1 with Stage I (>1.0 cm), II or III, Her-negative @entity0 from Georgia-based oncology network were randomized between Arm A: sequential therapy with D 100 mg/m(2) every 3 weeks for 4 cycles followed by C 1000 mg/m(2) PO BID on days 1-14 of 3 week cycle for 4 cycles; Arm B: concurrent therapy with with D 50 mg/m(2) on day 1 and C 1000 mg/m(2) PO BID on days 1-7 of 2 week cycle for 8 cycles. Primary endpoint was pCR rate; secondary endpoints included response rate and @entity137 . RESULTS: 51 @entity1 were accrued (4/2007-7/2009), Arm A (n=25) Arm B (n=26) and are evaluable for primary endpoint. @entity1 were accrued at academic center (45%), county hospital (33%), and community sites (22%). Median age was 50.3 years. Median @entity5 size was 6.1 cm. 35 of 51 (68.6%) were clinically node-positive at study entry. 57% of @entity1 were African American, 35% Caucasian, and 8% other. 30 of 51 (58.8%) of @entity1 had ER and/or PR-positive @entity5 ; 21 of 51 (41.2%) had ER/PR-negative @entity5 (triple negative). Treatment was well-tolerated with expected grade 3-4 @entity137 : @entity1398 15.7%; @entity8566 5.9%; @entity16 3.9%. On Arm A, clinical complete response (CR) rate was 32%. Partial response (PR) rate was 28%. @entity66 ( @entity66 ) rate was 12 %. @entity74 ( @entity74 ) rate was 28%. On Arm B, clinical CR rate was 46.2%. PR rate was 42.3%. @entity66 rate was 3.8%. @entity74 rate was 7.7%. pCR rate was 8% for Arm A and 11.5% for Arm B. Among triple negative @entity0 subjects, pCR rate was 19%. CONCLUSIONS: This is the first clinical trial to accrue @entity1 through a Georgia-based oncology trial network and more than half of enrolled @entity1 were African American. The final results from this phase II trial of D and C show that both regimens were well-tolerated and had modest clinical activity, with greater activity in the concurrent therapy arm and among triple negative @entity1 .

Final results from randomized phase II trial of preoperative docetaxel (D) and capecitabine (C) given sequentially or concurrently for @entity1722 -negative XXXX .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancers', 'breast cancer'] @entity66 :: ('MESH:D004194', 'Disease') :: ['Stable disease', 'SD'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor', 'tumors'] @entity16 :: ('MESH:D009422', 'Disease') :: ['neuropathy'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity8566 :: ('MESH:D060831', 'Disease') :: ['hand-foot syndrome'] @entity74 :: ('MESH:D030342', 'Disease') :: ['Progressive disease', 'PD'] @entity1722 :: ('2064', 'Gene') :: ['Her2']
@entity0 :: (MESH:D001943,Disease) :: ['breast cancers']
