Letrozole in Preventing Breast Cancer in Postmenopausal Women
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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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: letrozole |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Prevention |
Official Title: | A Pilot Study of Aromatase Inhibitors for Women at Increased Risk of Breast Cancer Based on Estradiol Levels |
- Safety, acceptability, and adherence [ Designated as safety issue: Yes ]
- Effects on menopausal symptoms [ Designated as safety issue: No ]
- Effects on mammographic percent breast density [ Designated as safety issue: No ]
Estimated Enrollment: | 110 |
Study Start Date: | September 2000 |
OBJECTIVES:
Primary
- 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.
- Compare the effects of these regimens on menopausal symptoms (including hot flushes, weight changes, sexual functioning, and genitourinary effects), blood lipid levels, markers of bone turnover, and multidimensional quality of life in patients treated with these regimens.
Secondary
- Determine the effect of letrozole-induced reduction of plasma estradiol levels on mammographic percent breast density in these patients.
OUTLINE: This is a pilot, randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral letrozole once daily for 1 year. Patients may then receive additional oral letrozole once daily for up to 4 years.
- Arm II: Patients receive oral placebo once daily for 1 year. Patients may then receive oral letrozole once daily for up to 5 years.
In both arms, treatment continues in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
Quality of life is assessed at baseline and then at 3, 6, and 12 months.
PROJECTED ACCRUAL: A total of 110 patients (73 for arm I and 37 for arm II) will be accrued for this study.
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
United States, Texas | |
Dan L. Duncan Cancer Center at Baylor College of Medicine | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Judy Garber, MD | Dana-Farber Cancer Institute |
Principal Investigator: | Patricia A. Ganz, MD | Jonsson Comprehensive Cancer Center |
Additional Information:
No publications provided
ClinicalTrials.gov Identifier: | NCT00090857 History of Changes |
Obsolete Identifiers: | NCT00165529, NCT00577551 |
Other Study ID Numbers: | CDR0000375585, DFCI-00024, UCLA-0210012-02 |
Study First Received: | September 7, 2004 |
Last Updated: | April 10, 2009 |
Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer |
stage IIIC breast cancer stage IV breast cancer breast cancer in situ ductal breast carcinoma in situ |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Letrozole |
Aromatase Inhibitors Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on March 06, 2013