Studies & Results
BCIRG 005
A multicenter phase III randomized trial comparing docetaxel in combination with doxorubicin and cyclophosphamide (TAC) versus doxorubicin and cyclophosphamide followed by docetaxel (AC-T) as adjuvant treatment of operable breast cancer HER2neu negative patients with positive axillary lymph nodes
View FDA Study
Presentations
San Antonio Breast Cancer Symposium, 2018
Press MF, et al.
HER2/ERBB2 status in "HER2 equivocal" breast cancers by FISH and ASCO-CAP guidelines: False-positives due to heterozygous deletions of alternative control loci
ASCO Annual Meeting, 2016
Pan H, Gray R, Davies C, et al.
Long-term recurrence risks after use of endocrine therapy for only 5 years: Relevance of breast tumour characteristics.
San Antonio Breast Cancer Symposium, 2012
Christiansen J, Barakat N, Murphy D, et al
Her2 expression measured by AQUA analysis on BCIRG-005 and BCIRG-006 predicts the benefit of Herceptin therapy.
San Antonio Breast Cancer Symposium, 2008
Eiermann W, Pienkowski T, Crown J, et al
BCIRG 005 main efficacy analysis: a phase III randomized trial comparing docetaxel in combination with doxorubicin and cyclophosphamide (TAC) versus doxorubicin and cyclophosphamide followed by docetaxel (AC→T) in women with Her-2/neu negative axillary lymph node positive early breast cancer.
Publications
Press MF, Sauter G, Buyse M, et al.: HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials.
J Clin Oncol JCO.2016.66.6693, 2016
Mackey J, Penkowski T, Crown J, et al.: Long-term outcomes after adjuvant treatment of sequential versus combination docetaxel with doxorubicin and cyclophosphamide in node-positive breast cancer: BCIRG-005 randomized trial
Ann Oncol 27:1041-7, 2016
Stern HM, Gardner H, Burzykowski T, et al: PTEN Loss Is Associated with Worse Outcome in HER2-Amplified Breast Cancer Patients but Is Not Associated with Trastuzumab Resistance.
Clin Cancer Res Off J Am Assoc Cancer Res 21:2065–2074, 2015
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).
Breast Cancer Res Treat 138:99–108, 2013
Dang C: The End of an Era: Shall We Move Forward?
J Clin Oncol 29:3849–3851, 2011
Eiermann W, Pienkowski T, Crown J, et al: Phase III study of doxorubicin/cyclophosphamide with concomitant versus sequential docetaxel as adjuvant treatment in patients with human epidermal growth factor receptor 2-normal, node-positive breast cancer: BCIRG-005 trial.
J Clin Oncol Off J Am Soc Clin Oncol 29:3877–3884, 2011
Press MF, Sauter G, Buyse M, et al: Alteration of topoisomerase II-alpha gene in human breast cancer: association with responsiveness to anthracycline-based chemotherapy.
J Clin Oncol Off J Am Soc Clin Oncol 29:859–867, 2011
Press MF, et al.: Assessment of ERBB2/HER2 Status in HER2-Equivocal Breast Cancers by FISH and 2013/2014 ASCO-CAP Guidelines
JAMA Oncol. 2019 Mar 1;5(3):366-375.
For information on any of TRIO's clinical trials, please contact Valérie Bee, Director Project Management at valerie.bee@trioncology.org
Presentations
San Antonio Breast Cancer Symposium, 2018
Press MF, et al.
HER2/ERBB2 status in "HER2 equivocal" breast cancers by FISH and ASCO-CAP guidelines: False-positives due to heterozygous deletions of alternative control loci
ASCO Annual Meeting, 2016
Pan H, Gray R, Davies C, et al.
Long-term recurrence risks after use of endocrine therapy for only 5 years: Relevance of breast tumour characteristics.
San Antonio Breast Cancer Symposium, 2012
Christiansen J, Barakat N, Murphy D, et al
Her2 expression measured by AQUA analysis on BCIRG-005 and BCIRG-006 predicts the benefit of Herceptin therapy.
San Antonio Breast Cancer Symposium, 2008
Eiermann W, Pienkowski T, Crown J, et al
BCIRG 005 main efficacy analysis: a phase III randomized trial comparing docetaxel in combination with doxorubicin and cyclophosphamide (TAC) versus doxorubicin and cyclophosphamide followed by docetaxel (AC→T) in women with Her-2/neu negative axillary lymph node positive early breast cancer.
Publications
Press MF, Sauter G, Buyse M, et al.: HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials. J Clin Oncol JCO.2016.66.6693, 2016
Mackey J, Penkowski T, Crown J, et al.: Long-term outcomes after adjuvant treatment of sequential versus combination docetaxel with doxorubicin and cyclophosphamide in node-positive breast cancer: BCIRG-005 randomized trial Ann Oncol 27:1041-7, 2016
Stern HM, Gardner H, Burzykowski T, et al: PTEN Loss Is Associated with Worse Outcome in HER2-Amplified Breast Cancer Patients but Is Not Associated with Trastuzumab Resistance. Clin Cancer Res Off J Am Assoc Cancer Res 21:2065–2074, 2015
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). Breast Cancer Res Treat 138:99–108, 2013
Dang C: The End of an Era: Shall We Move Forward? J Clin Oncol 29:3849–3851, 2011
Eiermann W, Pienkowski T, Crown J, et al: Phase III study of doxorubicin/cyclophosphamide with concomitant versus sequential docetaxel as adjuvant treatment in patients with human epidermal growth factor receptor 2-normal, node-positive breast cancer: BCIRG-005 trial. J Clin Oncol Off J Am Soc Clin Oncol 29:3877–3884, 2011
Press MF, Sauter G, Buyse M, et al: Alteration of topoisomerase II-alpha gene in human breast cancer: association with responsiveness to anthracycline-based chemotherapy. J Clin Oncol Off J Am Soc Clin Oncol 29:859–867, 2011
Press MF, et al.: Assessment of ERBB2/HER2 Status in HER2-Equivocal Breast Cancers by FISH and 2013/2014 ASCO-CAP Guidelines JAMA Oncol. 2019 Mar 1;5(3):366-375.
For information on any of TRIO's clinical trials, please contact Valérie Bee, Director Project Management at valerie.bee@trioncology.org