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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
2016-08-25
NCT00382070Uploaded 08-11-2021
Access via NCI by Request
PDS UID: nci-data-476
A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
Provider Information
Provider Data DescriptionThere are two data submissions (NCT00382070-D1 and NCT00382070-D2) for PMID 30509771, the primary publication for NCT00382070 (NSABP-B-42). This dataset, NCT00382070-D1, contains baseline characteristic, survival, disease recurrence, and serious adverse event data.
SponsorNSABP Foundation Inc
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 patients with hormone receptor-positive breast cancer. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.
ConditionsBreast Cancer
Intervention TypeDrug: Letrozole
Other: Placebo
Drug(s)Drug: Letrozole
Total Enrolled3966
RandomizationRandomized
Blinding MethodDouble
Arms InterventionGroup 2 Letrozole - Experimental
Group 1 Placebo - Placebo Comparator
Secondary IDU10CA012027
PubMed (PMID)17239269
30509771
Collaborator(s)National Cancer Institute (NCI)
Novartis
Region(s)United States
Canada
Ireland
Age Range18 Years to 120 Years (ADULT, OLDER_ADULT)
Files: NCT00382070-D1
Data DictionaryNCT00382070-D1-Data-Dictionary_1.pdf
DATANCT00382070-D1-Dataset.txt
OTHERREADME.pdf
Files: NCT00382070-D2
Data DictionaryNCT00382070-D2-Data-Dictionary_1.pdf
DATANCT00382070-D2-Dataset.txt
OTHERREADME.pdf
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