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)
OBJECTIVES:
Primary
- To compare the disease-free survival of women with primary breast cancer treated with
letrozole vs placebo after completing approximately 5 years (i.e., 4½ - 6 years) of
aromatase inhibitor therapy (e.g., letrozole, anastrozole, or exemestane).
Secondary
- To compare the effect of these drugs on overall (all cause specific) mortality of these
patients.
- To compare the incidence of contralateral breast cancer in patients treated with these
drugs.
- To evaluate the long-term clinical and laboratory safety of aromatase inhibitor
therapy, particularly cardiovascular morbidity and mortality (e.g., significant
coronary artery disease, including myocardial infarction and angina requiring
percutaneous transluminal coronary angioplasty or coronary artery bypass graft, fatal
and nonfatal strokes, and all vascular deaths); incidence of all bone fractures (with
particular emphasis on hip and wrist fractures as indicators of osteoporosis); changes
in bone density; and common toxicities.
- To compare overall quality of life (QOL) and menopausal-specific QOL of patients
treated with these drugs.
OUTLINE: This is a multicenter study. Patients are stratified according to lymph node status
at diagnosis (negative vs positive vs unknown), prior adjuvant chemotherapy (yes vs no),
interval between last dose of aromatase inhibitor therapy and study randomization (< 6
months vs 6 months to 2 years), and duration of prior tamoxifen citrate use (0 vs < 2 years
vs 2 - 4½ years vs > 4½ years). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral letrozole once daily for up to 5 years in the absence of
unacceptable toxicity, disease recurrence, or development of a second malignancy.
- Arm II: Patients receive oral placebo once daily for up to 5 years in the absence of
unacceptable toxicity, disease recurrence, or development of a second malignancy.
Patients undergo bone mineral density measurement by DEXA scan at baseline (if not done
within 12 months of study entry), at 24 and 48 months during study therapy, and at the
completion of study therapy. Some patients also complete quality-of-life questionnaires at
baseline and at 12, 24, 36, 48, and 60 months.
After completion of study therapy, patients are followed annually.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Disease-free survival
8 years
No
Paul E. Goss, MD, PhD
Study Chair
Massachusetts General Hospital
Canada: Health Canada
MA17R
NCT00754845
October 2004
May 2015
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