SWOG clinical trial number
JMA17

A Phase III Randomized Double Blind Study of Letrozole Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen

Closed
Phase
Published
Abbreviated Title
ADJUVANT: Letrozole vs. Placebo
Activated
11/15/1998
Closed
08/31/2002

Research committees

Breast Cancer

Treatment

Letrozole

Eligibility Criteria Expand/Collapse

Hist. confirmed breast carcinoma surgically removed at time of original diagnosis with no evdience of metastatic disease; ER or PgR positive (unknown status OK if undeterminable by immunocytochemisty); post-menopausal; must have completed >= 4.5 years and < 6 years of adjuvant tamoxifen post-surgery; randomize within 3 months of discontinuation of tamoxifen; prior adjuvant chemo or RT for original disease OK; chest x-ray; bone scan (if alk. phos. >= 2X normal); abdominal ultrasound or liver scan or CT (if AST/ALT or alk. phos. >= 2X normal); WBC >= 3.0 X 109/L or granulocytes >= 1.5 X109/L; platelets >= 100 X 109/L; SGOT/SGPT < 2X IULN; MUST NOT be registered to a Southwest Oncology Group adjuvant breast cancer trial.

CANCER CONTROL CREDIT: 0.5
TREATMENT CREDIT: 1.0

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

2016

Extending aromatase-inhibitor adjuvant therapy to 10 years

PE Goss;JN Ingle;KI Pritchard;NJ Robert;H Muss;J Gralow;K Gelmon;T Whelan;K Strasser Weippl;S Rubin;K Sturtz;AC Wolff;E Winer;C Hudis;A Stopeck;JT Beck;J Kaur;K Whelan;D Tu;WR Parulekar New England Journal of Medicine Jul 21;375(3):209-219

PMid: PMID27264120 | PMC number: PMC5024713

2013

Impact of premenopausal status at breast cancer diagnosis in women entered on the placebo-controlled NCIC CTG MA17 trial of extended adjuvant letrozole

PE Goss;JN Ingle;S Martino;NJ Robert;H Muss;RB Livingston;NE Davidson;EA Perez;Y Chavarri-Guerra;D Cameron;KI Pritchard;T Whelan;LE Shepherd;D Tu Annals of Oncology 24(27):355-361;

PMid: PMID23028039 | PMC number: PMC3551482

2010

Quantitative protein and gene expression biomarkers of tamoxifen and letrozole recurrence in the NCIC CTG MA.17 cohort

DC Sgroi;DM Finkelstein;L Shepherd;JN Ingle;DL Rimm;H Sassano;P Porter;M Pins;S Paik;A Ristimaki;K Pritchard;D Tu;PE Goss San Antoino Breast Cancer Symposium, abst. #p3-10-26; poster

2008

Late extended adjuvant treatment with letrozole improves outcome in women with early-stage breast cancer who complete 5 years of tamoxifen [PMID 18332475]

PE Goss;J Ingle;JL Pater;S Martino;NJ Robert;HB Ross;MJ Piccart;M Castiglione;LE Shepherd;KI Pritchard;RB Livingston;NE Davidson;L Norton;EA Perez;J Abrams;DA Cameron;MJ Palmer;D Tu Journal of Clinical Oncology 26(12):1948-1955

Efficacy, toxicity, and quality of life in older women with early-stage breast cancer treated with letrozole or placebo after 5 years of tamoxifen: NCIC CTG intergroup trial MA.17

H Muss;J Ingle;S Martino;N Robert;J Pater;T Whelan;M Palmer;M Piccart;L Shepherd;Z He;P Goss Journal of Clinical Oncology, 26(12):1956-1964

PMid: PMID18332474 | PMC number: n/a

Intent-to-treat analysis of the placebo-controlled trial of letrozole for extended adjuvant therapy in early breast cancer: NCIC CTG MA.17 [PMID18332043]

J Ingle;D Tu;J Pater;H Muss;S Martino;N Robert;M Piccart;M Castiglione;L Shepherd;K Pritchard;R Livingston;N Davidson;L Norton;EA Perez;J Abrams;D Cameron;M Palmer;P Goss Annals of Oncology 19(5):877-882

2005

Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17

PE Goss;JN Ingle;S Martino;NJ Robert;HB Muss;MJ Piccart;M Castiglione;D Tu;LE Shepherd;KI Pritchard;RB Livingston;NE Davidson;L Norton;EA Perez;JS Abrams;DA Cameron;MJ Palmer;JL Pater Journal of the National Cancer Institute 97(17):1262-1271

2003

A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer

PE Goss;JN INgle;S Martino;NJ Robert;HB Muss;MJ Piccart;M Castiglione;D Tu;LE Shepherd;KI Pritchard;RB Livingston;NE Davidson;L Norton;EA Perez;JS Abrams;P Therasse;JM Palmer;JL Pater New England Journal of Medicine 349(19):1793-1802