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Status:

TERMINATED

Tamoxifen in Preventing Breast Cancer in Women at Increased Risk for Breast Cancer

Lead Sponsor:

University of Texas Southwestern Medical Center

Collaborating Sponsors:

National Cancer Institute (NCI)

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. The use of tamoxifen may be effective in preventing breast cancer. PURPOSE: T...

Detailed Description

OBJECTIVES: * Compare molecular markers of proliferation and apoptosis in breast epithelial tissue of women at increased risk for breast cancer treated with tamoxifen vs placebo. * Compare the modula...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • At increased risk for breast cancer, as defined by 1 of the following criteria:
  • Histologically confirmed lobular carcinoma in situ (LCIS) treated by local excision only
  • Composite increased breast cancer risk of ≥ 1.67% over 5 years, based on the following criteria:
  • Age
  • Number of first-degree female relatives with breast cancer
  • One or more prior breast biopsies
  • Fine-needle aspiration cytology of a non-cystic lesion in lieu of an open biopsy is considered a biopsy
  • Prior diagnosis of atypical hyperplasia of the breast
  • Age at first live birth
  • Nulliparity
  • Race
  • Age at onset of menarche
  • No prior or suspected invasive breast cancer or ductal carcinoma in situ
  • No clinical evidence of malignancy by physical examination, including a breast examination within the past 3 months
  • No evidence of suspicious or malignant disease or uncharacterized lesions on bilateral mammogram within the past 6 months
  • Normal gynecologic examination, including a bimanual pelvic examination and, if indicated, pap smear within the past 12 months
  • Hormone receptor status:
  • Not specified
  • PATIENT CHARACTERISTICS:
  • Age
  • 35 and over
  • Sex
  • Female
  • Menopausal status
  • Premenopausal and ovulating\*, defined as having regular menses for the past 6 months OR irregular menses with follicular phase (i.e., day 3) follicle-stimulating hormone level \< 20 mIU/mL OR
  • Postmenopausal NOTE: \* Ovulation is determined by day 21 progesterone level \> 3 ng/mL
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Complete blood count normal
  • No active bleeding disorder (e.g., qualitative or quantitative platelet abnormality, hemophilia, or von Willebrand's disease)
  • Hepatic
  • Liver function tests normal
  • Renal
  • Not specified
  • Cardiovascular
  • No prior deep-vein thrombosis except a single occurrence related to lower extremity trauma
  • No prior cerebral vascular accident
  • No prior transient ischemic attack
  • Pulmonary
  • No prior pulmonary embolus except a single occurrence related to lower extremity trauma
  • Other
  • No saline or silicone breast implants
  • No known allergy to tamoxifen
  • No macular degeneration
  • No malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No nonmalignant disease that would preclude administration of tamoxifen
  • No psychiatric condition, including a history of clinical depression or addictive disorder, that would preclude giving informed consent or study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception during and for 3 months after study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • No prior systemic adjuvant chemotherapy for LCIS
  • Endocrine therapy
  • No prior tamoxifen, raloxifene, or other selective estrogen-receptor modulators
  • At least 3 months since prior and no concurrent use of any of the following drugs:
  • Estrogen or progesterone replacement therapy
  • Oral contraceptives
  • Androgens
  • Luteinizing hormone-releasing hormone analogs
  • Prolactin inhibitors
  • Antiandrogens
  • Steroids
  • No concurrent steroids for asthma
  • Radiotherapy
  • No prior radiotherapy for LCIS
  • Surgery
  • No prior bilateral prophylactic mastectomy
  • No prior mastectomy for LCIS
  • Other
  • Concurrent nonhormonal medications allowed
  • No concurrent warfarin or cholestyramine
  • No prior or concurrent participation in any other cancer prevention study
  • Patients treated with placebo on protocol NSABP-P-1 are eligible

Exclusion

    Key Trial Info

    Start Date :

    February 1 2000

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 15 2007

    Estimated Enrollment :

    130 Patients enrolled

    Trial Details

    Trial ID

    NCT00096369

    Start Date

    February 1 2000

    End Date

    March 15 2007

    Last Update

    January 24 2019

    Active Locations (4)

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

    Page 1 of 1 (4 locations)

    1

    Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, United States, 73104

    2

    Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, United States, 75390

    3

    M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, United States, 77030-4009

    4

    Cancer Therapy and Research Center

    San Antonio, Texas, United States, 78229