A randomized phase II trial of preoperative docetaxel (D) and capecitabine (C) given sequentially or concurrently for Her2 negative breast cancers.

Abstract

Abstract Abstract #5122 Background The efficacy of D and C as single agents and in combination is well established in the treatment of metastatic breast cancer. Novel sequential and concurrent regimens of D and C were evaluated in patients with her2-negative breast cancer eligible for preoperative therapy. MethodsPatients with Stage I (>1.0cm), II or III, Her2- breast cancer were randomized to two treatment arms: Arm A: sequential therapy with D 100 mg/m2 Q 3 weeks for 4 cycles, followed by C 1000mg/m2 BID on days 1-14 of a 3-week cycle, for 4 cycles; Arm B: concurrent therapy with D 50mg/m2 on day 1 and C 1000mg/m2 BID on days 1-7 of a 2-week cycle for 8 cycles. The planned total dose of D and C and number of cycles were identical on both arms. Tissue was collected at baseline, midway and post-therapy for correlative studies. Endpoints included pathologic complete response (pCR) rate, response rate, and toxicity. Results To date 38 of 80 planned patients have been accrued (4/07-6/08). Data are available for 33 patients; 16 African American (AA) (49%), 16 Caucasian (49%), and 1 Hispanic (2%). Patients were accrued from a university center (59%), county hospital (31%) and community sites (10%). Histology: Infiltrating ductal carcinoma (76%), infiltrating lobular carcinoma (15%), metaplastic tumors (6%), mucinous carcinoma (3%). Four patients had inflammatory breast cancer. 17 patients (52%) had ER+ or PR+ tumors and 16 (48%) had ER-/PR- tumors (triple negative tumors or TNT). The average tumor size at baseline was 4.0cm+/-3.0cm. In 29 patients who completed therapy, both regimens were relatively well tolerated: 9 patients (Arm A, N=3 (23%); Arm B, N=6 (38%)) had grade 3 toxicity, predominantly hand-foot syndrome, diarrhea or neuropathy. Dose reductions were required for 12 patients due to toxicity (11 required for C, 1 for D). To date, the pCR rate is 7%, observed only in AA patients with TNTs. In this subgroup the pCR rate was 18%.
 
 Discussion This study represents the first effort to accrue patients through a Georgia-based trial network, providing a unique opportunity to treat patients from a region with a large AA population. Our preliminary results suggest modest activity of D and C, with greater activity in the concurrent arm and in AA patients with TNTs. An official interim analysis is planned and updated results will be presented. Correlative studies which focus on molecular differences in responders and non-responders, particularly in the TNT group will be presented. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 5122.