Studies & Results
BCIRG 006
Multicenter phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC-T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC-TH) and with docetaxel, carboplatin and trastuzumab (TCH) in the adjuvant treatment of node positive and high risk node negative patients with operable breast cancer containing the HER2neu alteration
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Presentations
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.
ASCO Annual Meeting, 2011.
Valero V, Slamon DJ, Eiermann W, et al
Efficacy results of node-negative HER2-amplified breast cancer subset from BCIRG 006 study: A 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).
San Antonio Breast Cancer Symposium, 2009
Slamon D, Eiermann W, Robert NJ, et al
Phase III Trial Comparing AC - T with AC - TH and with TCH in the Adjuvant Treatment of HER2 positive Early Breast Cancer Patients: Third Interim Efficacy Analysis.
San Antonio Breast Cancer Symposium, 2007
Au H-J, Robert N, Eiermann W, et al
BCIRG 006: quality of life (QoL) of patients (pts) treated with docetaxel and trastuzumab-based regimens in node positive and high risk node negative HER2 positive early breast cancer.
ASCO Annual Meeting, 2007
Press MF, Sauter F, Buyse M, et al
Alteration of Topoisomerase II-alpha Gene in Human Breast Cancer: Association with Responsiveness to Anthracycline-Based Chemotherapy.
San Antonio Breast Cancer Symposium, 2006
Slamon D, Eiermann W, Robert N, et al
Phase III Trial Comparing AC - T with AC - TH and with TCH in the Adjuvant Treatment of HER2 positive Early Breast Cancer Patients: Second Interim Efficacy Analysis.
San Antonio Breast Cancer Symposium, 2005
Press MF
Topoisomerase II-alpha gene amplification as a predictor of responsiveness to anthracyclin-containing chemotherapy in the BCIRG 006 trial of trastuzumab in the adjuvant setting.
San Antonio Breast Cancer Symposium, 2005
Slamon D, Eiermann W, Robert N, et al
Phase III Trial Comparing AC - T with AC - TH and with TCH in the Adjuvant Treatment of HER2 positive Early Breast Cancer Patients: First Interim Efficacy Analysis.
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
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
Au H-J, Eiermann W, Robert NJ, et al: Health-related quality of life with adjuvant docetaxel- and trastuzumab-based regimens in patients with node-positive and high-risk node-negative, HER2-positive early breast cancer: results from the BCIRG 006 Study.
The Oncologist 18:812–818, 2013
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
Hayes DF: Steady Progress against HER2-Positive Breast Cancer.
N Engl J Med 365:1336–1338, 2011
Slamon D, Eiermann W, Robert N, et al: Adjuvant trastuzumab in HER2-positive breast cancer.
N Engl J Med 365:1273–1283, 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
Nabholtz J, Reese D, Lindsay M, et al.: HER2-positive breast cancer: update on Breast Cancer International Research Group trials
Clinic Breast 3:S75-9, 2002
For information on any of TRIO's clinical trials, please contact Valérie Bee, Director Project Management at valerie.bee@trioncology.org
Presentations
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.
ASCO Annual Meeting, 2011.
Valero V, Slamon DJ, Eiermann W, et al
Efficacy results of node-negative HER2-amplified breast cancer subset from BCIRG 006 study: A 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).
San Antonio Breast Cancer Symposium, 2009
Slamon D, Eiermann W, Robert NJ, et al
Phase III Trial Comparing AC - T with AC - TH and with TCH in the Adjuvant Treatment of HER2 positive Early Breast Cancer Patients: Third Interim Efficacy Analysis.
San Antonio Breast Cancer Symposium, 2007
Au H-J, Robert N, Eiermann W, et al
BCIRG 006: quality of life (QoL) of patients (pts) treated with docetaxel and trastuzumab-based regimens in node positive and high risk node negative HER2 positive early breast cancer.
ASCO Annual Meeting, 2007
Press MF, Sauter F, Buyse M, et al
Alteration of Topoisomerase II-alpha Gene in Human Breast Cancer: Association with Responsiveness to Anthracycline-Based Chemotherapy.
San Antonio Breast Cancer Symposium, 2006
Slamon D, Eiermann W, Robert N, et al
Phase III Trial Comparing AC - T with AC - TH and with TCH in the Adjuvant Treatment of HER2 positive Early Breast Cancer Patients: Second Interim Efficacy Analysis.
San Antonio Breast Cancer Symposium, 2005
Press MF
Topoisomerase II-alpha gene amplification as a predictor of responsiveness to anthracyclin-containing chemotherapy in the BCIRG 006 trial of trastuzumab in the adjuvant setting.
San Antonio Breast Cancer Symposium, 2005
Slamon D, Eiermann W, Robert N, et al
Phase III Trial Comparing AC - T with AC - TH and with TCH in the Adjuvant Treatment of HER2 positive Early Breast Cancer Patients: First Interim Efficacy Analysis.
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
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
Au H-J, Eiermann W, Robert NJ, et al: Health-related quality of life with adjuvant docetaxel- and trastuzumab-based regimens in patients with node-positive and high-risk node-negative, HER2-positive early breast cancer: results from the BCIRG 006 Study. The Oncologist 18:812–818, 2013
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
Hayes DF: Steady Progress against HER2-Positive Breast Cancer. N Engl J Med 365:1336–1338, 2011
Slamon D, Eiermann W, Robert N, et al: Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med 365:1273–1283, 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
Nabholtz J, Reese D, Lindsay M, et al.: HER2-positive breast cancer: update on Breast Cancer International Research Group trials Clinic Breast 3:S75-9, 2002
For information on any of TRIO's clinical trials, please contact Valérie Bee, Director Project Management at valerie.bee@trioncology.org