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

Closed
Phase
Published
Abbreviated Title
ADJUVANT: AC -> T vs AC -> T -> trastuzumab (Herceptin) vs AC -> T/trastuzumab
Activated
07/01/2000
Closed
04/30/2005
Participants
NCORP, Members, Medical Oncologists, Surgeons, Affiliates

Research committees

Breast Cancer

Treatment

Cyclophosphamide Paclitaxel Doxorubicin Herceptin Surgery AC

Eligibility Criteria Expand/Collapse

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.

Publication Information Expand/Collapse

2020

Economic evaluations in NCI-sponsored network cancer clinical trials

VT Nghiem;R Vaidya;GH Lyman;DL Hershman;SD Ramsey;JM Unger Value in Health Dec;23(12):1653-1661. doi: 10.1016/j.jval.2020.08.2095. Epub 2020 Oct 9

PMid: PMID33248521 | PMC number: PMC8262264

Impact of Adjuvant Trastuzumab on Locoregional Failure Rates in the NCCTG N9831 (Alliance) Study

C Vargas;C Thorpe;A Dueck;K Tenner;E Perez;E Hwang;M Halyard;T Pisansky;N Davidson;S Martino;B Pockaj Cancer Sep 15. doi: 10.1002/cncr.33154. Online ahead of print.

PMC number: PMID32931029

2019

Impact of Adjuvant Trastuzumab on Locoregional Failure Rates in the NCCTG N9831 (Alliance) Study

C Thorpe;C Vargas;A Dueck;K Tenner;E Perez;ES Hwang;M Halyard;T Pisansky;S Martino;N Davidson;B Pockaj ASTRO Annual Meeting (9/15-18/2019, Chicago IL), oral

2015

Genomic analysis reveals that immune function genes are strongly linked to clinical outcome in the north central cancer treatment group N9831 adjuvant trastuzumab trial

EA Perez;EA Thompson;KV Ballman;SK Anderson;Y Asmann;K Kalari;J Eckel-Passow;AC Dueck;KS Tenner;J Jenn;J-B Fan;X Geiger;A McCullough;B Chen;RB Jenkins;G Sledge;E Winer;JR Gralow;MM Reinholz Journal of Clinical Oncology Mar 1;33(7):701-708

PMid: PMID25605861 | PMC number: PMC4334774

The relationship between quantitative human epidermal growth factor receptor 2 gene expression by the 21-gene reverse transcriptase polymerase chain reaction assay and adjuvant trastuzumab benefit in Alliance N9831

EA Perez;F Baehner;S Butler;EA Thompson;A Dueck;F Jamshidian;D Cherbavaz;C Yoshizawa;S Shak;P Kaufman;N Davidson;J Gralow;Y Asmann;K Ballman Breast Cancer Research, Oct 1;17(1):133

PMid: PMID26429296 | PMC number: PMC4589954

2014

EGFR expression is associated with decreased benefit from trastuzumab in the NCCTG N9831 (Alliance) trial

H Cheng;K Ballman;M Vassilakopoulou;AC Dueck;MM Reinholz;K Tenner;J Gralow;C Hudis;NE Davidson;G Fountzilas;A McCullough;B Chen;A Psyrri;D Rimm;EA Perez British Journal of Cancer 111(6):1065-1071;

PMid: PMID25117817 | PMC number: PMC4453859

Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831

EA Perez;EH Romond;VJ Suman;JH Jeong;G Sledge;CE Geyer;S Martino;P Rastogi;J Gralow;S Swain;E Winer;G Colon-Otero;NE Davidson;E Mamounas;JA Jujewski;N Wolmark Journal of Clinical Oncology Nov 20;32(33):3744-3752

PMid: PMID25332249 | PMC number: PMC4226805

2013

The relationship between quantitative HER2 gene expression by the 21-gene RT-PCR assay and adjuvant trastuzumab (H) benefit in NCCTG (Alliance) N9831

EA Perez;SM Butler;AC Dueck;F Baehner;F Jamshidian;DB Cherbavaz;EA Thompson;S Shak;PA Kaufman;NE Davidson;J Gralow;Y Asmann;KV Ballman Journal of Clinical Oncology 31(suppl; abstr 520)

Impact of c-myc protein expression on outcome of patients with early-stage HER2+ breast cancer treated with adjuvant trastuzumab NCCTG (Alliance) N9831

AC Dueck;MM Reinholz;XJ Geiger;K Tenner;K Ballman;RB Jenkins;D Riehle;B Chen;AE McCullough;N Davidson;S Martino;GW Sledge;PA Kaufman;LA Kutteh;J Gralow;LN Harris;JN Ingle;WL Lingle;EA Perez Clinical Cancer Research 19(20):5798-5807;

PMid: PMID23965903 | PMC number: PMC3805021

Soluble human epidermal growth factor receptor 2 (HER2) levels in patients with HER2-positive breast cancer receiving chemotherapy with or without trastuzumab: results from North Central Cancer Treatment Group adjuvant trial N9831

A Moreno-Aspitia;DW Hillman;SH Dyar;KS Tenner;J Gralow;P Kaufman;NE Davidson;JM Lafky;M Reinholz;WL Likngle;LA Kutteh;WP Carney;AC Dueck;AE Perez Cancer 119(15):2675-2682

PMid: PMID23744760 | PMC number: PMC4126833

Impact of PTEN protein expression on benefit from adjuvant trastuzumab in early stage human epidermal growth factor receptor 2-positive breast cancer in the North Central Cancer Treatment Group N9831 trial

A Perez;A Dueck;A McCullough;B Chen;X Geiger;R Jenkins;W Lingle;N Davidson;S Martino;P Kaufman;LA Kutteh;G Sledge;L Harris;J Gralow;M Reinholz Journal of Clinical Oncology 31(17):2115-2122

PMid: PMID23650412 | PMC number: PMC3731983

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

Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31.

EA Perez;EH Romond;VJ Suman;J-H Jeong;CE Geyer;S Martino;E Mamounas;PA Kaufman;N Wolmark Journal of Clinical Oncology 29(25):3366-3373

PMid: PMID21768458 | PMC number: PMC3164242

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

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