SWOG clinical trial number
N9831
Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Overexpressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer
Abbreviated Title
ADJUVANT: AC -> T vs AC -> T -> trastuzumab (Herceptin) vs AC -> T/trastuzumab
Treatment
Cyclophosphamide
Paclitaxel
Doxorubicin
Herceptin
Surgery
AC
Operable, histologically confirmed female breast adenocarcinoma with positive lymph nodes (either by axillary node dissection or sentinal node finding) or high-risk node negative as defined in the protocol; one or more positive nodes whose tumors are T 1-3, pN1-2, M0; no cN2; no locally advanced tumors (T4) or peau d' orange; no bilateral invasive carcinoma and/or DCIS; metaplastic carcinoma OK; no prior therapy for breast cancer; no active cardiac disease; ER/PgR determination required; overexpression of HER-2/neu; <= 84 days from mastectomy or from axillary dissection or sentinal node detection; no evidence of gross or microscopic tumor at the surgical resection margins; no gross residual adenopathy; may have received up to 4
weeks of tamoxifen or other hormonal agent; may have received tamoxifen or raloxifene for chemoprevention but must be discontinued; >= 18 years; ANC >= 1,500; PLT >= 100,000; bilirubin <= 1.5 x UNL; AST <= 2.0 x UNL; normal LVEF; any hormonal treatment must be discontinued; pts. with breast conserving surgery or with mastectomy and >= 4 positive nodes must plan RT following completion of chemotherapy; no sensitivity to benzyl alcohol; no neurology/neuropathy-sensory toxicities >= Grade 2 per NCI CTC.
2012
Predictability of adjuvant trastuzumab benefit in N9831 patients using the ASCO/CAP HER2-positivity criteria [PMID22138096; PMC3260130]
EA Perez;AC Dueck;A McMullough;M Reinholz;K Tenner;N Davidson;J Gralow;LA Kutteh;DH Hillman;RB Jenkins;B Chen Journal of the National Cancer Institute 104(2):159-162
2011
C-MYC alterations and association with patient outcome in early-stage HER2-positive breast cancer from the North Central Cancer Treatment Group N9831 adjuvant trastuzumab trial [PMID21245420; PMC3056653]
EA Perez;RB Jenkins;AC Dueck;AE Wiktor;PP Bedroske;SK Anderson;RP Kettering;WR Sukow;K Kanehira;B Chen;XJ Geiger;CA Andorfer;AE McCullough;N Davidson;S Martino;GW Sledge;PA Kaufman;LA Kutteh;J Gralow;LN Harris;JN Ingle;WL Lingle;MM Reinholz Journal of Clinical Oncology 29(6):651-659
Sequential versus concurrent trastuzumab in adjuvant chemotherapy for breast cancer [PMID22042958; PMC3236650]
EA Perez;VJ Suman;NE Davidson;J Gralow;PA Kaufman;DW Visscher;B Chen;JN Ingle;S Dakhil;J Zujewski;A Moreno-Aspitia;TM Pisansky;RB Jenkins Journal of Clinical Oncology 29(34):4491-4497
2010
HER2 and chromosome 17 effect on patient outcome in the N9831 adjuvant trastuzumab trial [PMID20697084; PMC2954132]
EA Perez;MM Reinholz;DW Hillman;KS Tenner;MJ Schroeder;NE Davidson;S Martino;G Sledge;LN Harris;J Gralow;AC Dueck;RP Kettering;J Ingle;WL Lingle;PA Kaufman;DW Visscher;RB Jenkins Journal of Clinical Oncology 28(28):4307-4315
c-MYC (MYC) protein expression and associations iwth trastuzumab benefit in early-stage, HER2+ breast cancer in context of the NCCTG adjuvant trial, N9831
MM Reinholz;AC Dueck;AE Wiktor;WL Lingle;RB Jenkins;NE Jenkins;S Martino;PA Kaufman;LA Kutteh;G Sledge;LN Harris;JR Gralow;X Geiger;EA Perez San Antonio Breast Cancer Symposium, abst. #P2-09-08; poster
2009
Radiotherapy and adjuvant trastuzumab in operable breast cancer: tolerability and adverse event data from the North Central Cancer Treatment Group Phase 3 trial (N9831) [PMC2690390; PMID19349549]
MY Halyard;TM Pisansky;AC Dueck;V Suman;L Pierce;L Solin;L Marks;N Davidson;S Martino;P Kaufman;L Kutteh;SR Dakhil;EA Perez Journal of Clinical Oncology 27(16):2638-2644
Results of chemotherapy alone, with sequential or concurrent addition of 52 weeks of trastuzumab in the NCCTG N9831 HER2-positive adjuvant breast cancer trial
E Perez;VJ Suman;NE Davidson;J Gralow;P Kaufman;JN Ingle;SR Dakhil;J Zujewski;TM Pisansky;R Jenkins San Antonio Breast Cancer Symposium abst. #80 (annual meeting, general session)
2007
A correlative study of cardiac biomarkers and left ventricular ejection fraction (LVEF) from N9831, a phase III randomized trial of chemotherapy and trastuzumab as adjuvant therapy for HER-2 positive breast cancer.
L Kutteh;T Hobday;A Jaffe;B Laplante;D Hillman;P Kaufman;N Davidson;S Martino;E Perez Proc of the American Society of Clinical Oncology, Journal of Clinical Oncology 25(18S):#579
2006
Adjuvant radiotherapy (RT) and trastuzumab in stage I-IIA breast cancer: toxicity data from North Central Cancer Treatment Group phase III trial N9831
MY Halyard;TM Pisansky;LJ Solin;LB Marks;LJ Pierce;A Dueck;EA Perez Journal of Clinical Oncology 24 (18S):523
2005
Exploratory analysis from NCCTG N9831: do clinical and laboratory characteristics predict cardiac toxicity of trastuzumab when administered as a component of adjuvant therapy?
EA Perez;VJ Suman;NE Davidson;PA Kaufman;S Martino;SR Dakhil;JN Ingle;RJ Rodeheffer;BJ Gersh;AS Jaffe Breast Cancer Research and Treatment 94(Suppl 1):S96(#2038)
Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer
EH Romond;EA Perez;J Bryant;VJ Suman;CE Geyer, Jr;NE Davidson;E Tan-Chiu;S Martino;S Paik;PA Kaufman;SM Swain;TM Pisansky;L Fehrenbacher;LA Kutteh;VG Vogel;DW Visscher;G Yothers;RB Jenkins;AM Brown;SR Dakhil;E Mamounas;WL Lingle;PM Klein;JN Ingle;N Wolmark New England Journal of Medicine 353(16):1673-1684
