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Similarly, in the BCIRG central testing clinical trial data, of the limited cases (nine total) with IHC data and ISH results in this category, one was IHC 3+ positive, one was IHC 2 +, and seven were IHC negative.
Study Control Trastuzumab Reduction in DFS arm arm relative risk hazard of recurrence ratio NSABP B-31 AC [right AC [right arrow] T arrow] TH Joint analysis 0.48 (N = 2700) NCCTG 52% N9831 AC [right AC [right arrow] T arrow] TH (N = 3300) HERA Any Trastuzumab (N = 5090) 1 year 46% 0.54 BCIRG 006 AC [right AC [right 40% 0.49 arrow] D arrow] DH 33% 0.61 (N = 3150) DCH FINHer D [right DH [right arrow] FEC arrow] FEC (N = 232) V [right VH [right 0.42 arrow] FEC arrow] FEC NSABP, National Surgical Adjuvant Breast and Bowel Project; NCCTG, North Central Cancer Treatment Group; HERA, Herceptin Adjuvant Trial; BCIRG, Breast Cancer International Research Group; FINHer, Finland Herceptin Study.
Phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC TH) with docetaxel, carboplatin and trastuzumab (TCH) in Her2neu positive early breast cancer patients: BCIRG 006 Study.
BCIRG 006 randomized 3,222 patients with HER2-positive breast cancer and positive lymph nodes or other high-risk features to one of three treatment arms: a control regimen involving standard potent anthracycline-based chemotherapy with four cycles of doxorubicin and cyclophosphamide followed by four of docetaxel; the same regimen, plus 1 year of adjuvant trastuzumab starting concurrent with the docetaxel: or a year of trastuzumab starting at the outset of six cycles of docetaxel and carboplatin.
Women on the new regimen were 32 per cent less likely to get recurrent tumours and almost 50 per cent less likely to have their cancer return and spread throughout their bodies, according to BCIRG, which conducted the study.
Slamon, who presented the interim BCIRG 006 results at the symposium, said the study provided both good news and bad regarding trastuzumab's cardiotoxicity.
Full results from a further adjuvant study, Breast Cancer International Research Group (BCIRG) 006, may be informative in this regard; this study included node-negative tumours regardless of tumour size.
(22.) Perez EA, Press MF, Dueck AC, et al: Immunohistochemistry and fluorescence in situ hybridization assessment of HER2 in clinical trials of adjuvant therapy for breast cancer (NCCTG N9831, BCIRG 006, and BCIRG 005).
Phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (ACTH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2 positive early breast cancer patients: BCIRG 006 study.
BCIRG 006: 2nd interim analysis phase III randomized trial phase III comparing doxorubicin and cyclophosphamide followed by docetaxel (AC-T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC-TH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2 positive early breast cancer patients; San Antonio Breast Cancer Symposium.
As some of the clinical trials on Herceptin (such as NSABP B-31, BCIRG 006, NCCTG 9831) mature, some of these pivotal validation studies can be completed.
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