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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
2015-12-21
NCT00754845Uploaded 11-22-2018
Access via NCI by Request
PDS UID: nci-data-390
A Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed With Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen (Including Those in The MA.17 Study)
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the treatment comparison between letrozole group and the placebo group in trial NCT00754845.
SponsorCanadian Cancer Trials Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating in women with breast cancer who have already received 5 years of aromatase inhibitor therapy. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating women with primary breast cancer who have received 5 years of aromatase inhibitor therapy.
ConditionsBreast Cancer
Intervention TypeDrug: letrozole
Other: placebo
Drug(s)Drug: letrozole
Total Enrolled1918
RandomizationRandomized
Blinding MethodTriple
Arms InterventionLetrozole - Experimental
Placebo - Placebo Comparator
Secondary IDCAN-NCIC-MA17R
PubMed (PMID)27264120
34825307
33853037
29328860
Collaborator(s)Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
SWOG Cancer Research Network
Alliance for Clinical Trials in Oncology
Region(s)Canada
United Kingdom
Age Range0 Years to 120 Years (CHILD, ADULT, OLDER_ADULT)
Files: NCT00754845-D1
Data DictionaryNCT00754845-D1-Data-Dictionary.pdf
DATANCT00754845-D1-Dataset.csv
OTHERREADME.pdf
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