Phase 2
N=49
Letrozole in Preventing Breast Cancer in Postmenopausal Women
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00090857 ↗Enrolled (actual)
49
Serious AEs
2.0%
Results posted
Jun 2017
Primary outcome: Primary: Change in Lumbar Density From Baseline to 12 Months — -0.036; -0.021 g/cm^2 — p=0.15
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Letrozole (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Lumbar Density From Baseline to 12 Months |
-0.036; -0.021 | 0.15 |
| PRIMARY Change in Femoral Neck Density From Baseline to 12 Months |
-0.0065; -0.013 | 0.70 |
| PRIMARY Change in Trochanter Density From Baseline to 12 Months |
-0.017; -0.009 | 0.03 sig |
| PRIMARY Change in Hip Density From Baseline to 12 Months |
-0.0275; -0.001 | 0.06 |
| SECONDARY Worst Grade Hot Flashes |
14; 9; 5; 3; 11; 4 | 0.38 |
| SECONDARY Worst Grade Muscle Aches/Pains |
14; 13; 8; 2; 7; 1 | 0.02 sig |
| SECONDARY Worst Grade Nausea |
23; 15; 5; 1; 1; 0 | 0.20 |
| SECONDARY Worst Grade Vomiting |
28; 15; 1; 0; 0; 1 | .88 |
| SECONDARY Worst Grade Abdominal Pain |
27; 16; 3; 0; 3; 0 | 0.27 |
| SECONDARY Worst Grade Bone Pain |
22; 12; 2; 3; 6; 1 | .60 |
| SECONDARY Worst Grade Headache |
20; 11; 7; 3; 3; 2 | .58 |
| SECONDARY Worst Grade Fatigue |
19; 11; 6; 2; 5; 3 | .49 |
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- At increased risk for the development or recurrence of breast cancer, defined as an estradiol level ≥ 9 pg/mL
- No evidence of suspicious or malignant disease, based on the following examinations:
- Clinical bilateral breast examination within the past 6 months
- Bilateral* mammogram within 3 months before randomization OR within 30 days after randomization
- Pelvic exam normal within the past 5 years
- General physical exam within the past 6 months NOTE: *Unilateral mammogram of the uninvolved breast for patients with prior invasive breast cancer or ductal carcinoma in situ (DCIS)
- Bone density scan within 2 standard deviations from normal within the past 30 days
- Bone density scan ≥ 2 standard deviations below normal allowed if approved by the study physician
- At least 1 breast that has not been previously treated with radiotherapy or surgery (for patients with prior invasive breast cancer or DCIS)
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 35 and over
Sex
- Female
Menopausal status
- Postmenopausal, defined by any of the following criteria:
- At least 12 months without spontaneous menstrual bleeding
- Prior hysterectomy and bilateral salpingo-oophorectomy
- ≥ 55 years of age with a prior hysterectomy with or without oophorectomy
- < 55 years of age with a prior hysterectomy without oophorectomy OR the status of the ovaries is unknown AND follicle-stimulating hormone (FSH) level is in the postmenopausal range
Performance status
- Normal activity must not be restricted for a significant portion of the day
Life expectancy
- At least 10 years
Hematopoietic
- Complete blood count with differential normal
- Prior benign neutropenia allowed provided the granulocyte count is ≥ 1,500/mm^3
Hepatic
- Bilirubin normal
- Alkaline phosphatase normal
- SGOT and SGPT normal
Renal
- Creatinine normal
Cardiovascular
- No uncontrolled cardiovascular disease
Other
- Not pregnant
- No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No osteoporosis
- No hyperlipidemia
- No mental health status resulting in cognitive or emotional impairment that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- More than 30 days since prior AND no concurrent use of any of the following hormonal agents:
- Estrogen or progesterone replacement therapy
- Oral contraceptives
- Raloxifene or other plasma estrogen receptor modulators (SERMs)
- Androgens (e.g., danazol)
- Luteinizing hormone-releasing hormone (LHRH) analogs (e.g., goserelin or leuprolide)
- Prolactin inhibitors (e.g., bromocriptine)
- Antiandrogens (e.g., cyproterone)
- More than 60 days since prior AND no concurrent tamoxifen
- No prior aromatase inhibitors (for patients with prior invasive breast cancer or DCIS)
- No concurrent phytoestrogenic dietary supplements (e.g., soy, ginseng, or other natural products)
- Dietary soy allowed
Radiotherapy
- See Disease Characteristics
Surgery
- See Disease Characteristics
- No prior bilateral mastectomy
Other
- More than 60 days since prior treatment for invasive breast cancer or DCIS
- More than 30 days since prior bisphosphonates or calcitonin
- No prior or concurrent participation on a treatment study for invasive breast cancer or DCIS
- No concurrent participation in any other cancer prevention study or osteoporosis prevention study involving pharmacologic agents
- No concurrent calcitonin
- No concurrent bisphosphonate therapy
- Concurrent cholecalciferol (vitamin D) and calcium to augment bone mineral density allowed
Data sourced from ClinicalTrials.gov (NCT00090857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.