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Status:

COMPLETED

Letrozole in Preventing Breast Cancer in Postmenopausal Women

Lead Sponsor:

Dana-Farber Cancer Institute

Collaborating Sponsors:

National Cancer Institute (NCI)

Jonsson Comprehensive Cancer Center

Conditions:

Breast Cancer

Eligibility:

FEMALE

35-120 years

Phase:

PHASE2

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 brea...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    February 1 2002

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2013

    Estimated Enrollment :

    49 Patients enrolled

    Trial Details

    Trial ID

    NCT00090857

    Start Date

    February 1 2002

    End Date

    March 1 2013

    Last Update

    March 30 2018

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Massachusetts General Hospital

    Boston, Massachusetts, United States, 02114

    2

    Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, United States, 02115

    3

    Beth Israel Deaconess Medical Center

    Boston, Massachusetts, United States, 02215

    4

    Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, United States, 19104-4283