Letrozole in Preventing Breast Cancer in Postmenopausal Women
- Registration Number
- NCT00090857
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Letrozole may be effective in preventing the development or recurrence of breast cancer in postmenopausal women who are at increased risk of developing breast cancer because of elevated estradiol levels.
PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women with elevated estradiol levels.
- Detailed Description
OBJECTIVES:
Primary
* The primary outcome of the study is the change in bone mineral density following a year on letrozole vs. a year on placebo.
Secondary
* Compare the safety, acceptability, and adherence to letrozole vs placebo in postmenopausal women at increased risk for the development or recurrence of breast cancer based on elevated plasma estradiol levels through evaluation of menopausal symptoms (including hot flushes, weight changes, sexual functioning, and genitourinary effects), blood lipid levels, markers of bone turnover, and multidimensional quality of life.
* Determine the effect of letrozole-induced reduction of plasma estradiol levels on mammographic percent breast density.
* Obtain background information for a future large chemoprevention trial to address the question of whether a reduction in plasma estradiol levels can reduce the risk of breast cancer in postmenopausal women.
OUTLINE: This is a pilot, randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 2:1 (experimental treatment: placebo arms).
PROJECTED ACCRUAL: A total of 110 patients (73 for arm I and 37 for arm II) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 49
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer. Letrozole Letrozole Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
- Primary Outcome Measures
Name Time Method Change in Lumbar Density From Baseline to 12 Months Evaluation occurred at treatment initiation (BL) and after 12-months of treatment. The bone mineral density (BMD) test was comprised of the following 4 measurements \[total density (g/cm\^2)\]: lumbar, femoral neck, trochanter, hip.
Change in Hip Density From Baseline to 12 Months Evaluation occurred at treatment initiation (BL) and after 12-months of treatment. The bone mineral density (BMD) test was comprised of the following 4 measurements \[total density (g/cm\^2)\]: lumbar, femoral neck, trochanter, hip.
Change in Femoral Neck Density From Baseline to 12 Months Evaluation occurred at treatment initiation (BL) and after 12-months of treatment. The bone mineral density (BMD) test was comprised of the following 4 measurements \[total density (g/cm\^2)\]: lumbar, femoral neck, trochanter, hip.
Change in Trochanter Density From Baseline to 12 Months Evaluation occurred at treatment initiation (BL) and after 12-months of treatment. The bone mineral density (BMD) test was comprised of the following 4 measurements \[total density (g/cm\^2)\]: lumbar, femoral neck, trochanter, hip.
- Secondary Outcome Measures
Name Time Method Worst Grade Muscle Aches/Pains Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months. Participants reported worst grade muscle aches/pains defined as grade 01: mild, 02: moderate, 03: severe (CTCAEv3) or 04: disabling (CTCAEv3) during 12 months of treatment.
Worst Grade Vomiting Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months. Participants reported worst grade vomiting grade 01: 1x in 24 hours, 02: 2-5x in 24 hours, 03: \>/= 6x in 24 hours, grade 04: requiring parenteral nutrition/intensive care during 12 months of treatment.
Worst Grade Headache Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months. Participants reported worst grade headache: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.
Worst Grade Fatigue Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months. Participants reported worst grade fatigue: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.
Worst Grade Hot Flashes Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months. Participants reported worst grade hot flashes: 01: mild (\<1qd) or 02: moderate (\>1qd) during 12 months of treatment.
Worst Grade Nausea Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months. Participants reported worst grade nausea grade 01: able to eat, 02: oral intake significantly decreased, 03: no significant intake, requiring IV fluids during 12 months of treatment.
Worst Grade Bone Pain Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months. Participants reported worst grade bone pain: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.
Worst Grade Abdominal Pain Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months. Participants reported worst grade abdominal pain: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.
Trial Locations
- Locations (5)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Dan L. Duncan Cancer Center at Baylor College of Medicine
🇺🇸Houston, Texas, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States