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Status:

TERMINATED

S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women

Lead Sponsor:

SWOG Cancer Research Network

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Eligibility:

FEMALE

18-120 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 celecoxib may be effective in preventing breast cancer. PURPOSE: T...

Detailed Description

OBJECTIVES: * Compare 1-year mammographic density in premenopausal women at high risk for developing breast cancer treated with celecoxib vs placebo. * Compare 1-year proliferation of breast epitheli...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • At elevated risk of developing breast cancer, as defined by 1 of the following:
  • Modified Gail risk at 5 years ≥ 1.7% or lifetime risk ≥ 20% AND Claus Model, BRCAPro Model, or Tyrer-Cuzick Model lifetime risk ≥ 20%
  • Diagnosis of lobular carcinoma in situ or ductal carcinoma in situ
  • Known deleterious mutation of BRCA1 or BRCA2
  • At least 1 breast available for imagery and biopsy
  • Has undergone a baseline mammogram with a standard density wedge within 7-14 days after completion of the last menstrual period AND within 7 days before study entry
  • Mammogram normal or benign (BIRADS score 0 or 1)
  • Hormone receptor status:
  • Not specified
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Sex
  • Female
  • Menopausal status
  • Premenopausal, defined by 1 of the following criteria:
  • Last menstrual period \< 6 months ago AND no prior bilateral ovariectomy AND not on estrogen replacement therapy
  • Prior hysterectomy (with ovaries still in place) AND normal follicle-stimulating hormone levels within 28 days of study entry
  • Performance status
  • Zubrod 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Not specified
  • Hepatic
  • Bilirubin \< 2.0 times institutional upper limit of normal (IULN)
  • SGOT or SGPT \< 2 times IULN
  • Alkaline phosphatase \< 2 times IULN
  • INR ≤ 1.5
  • PT and PTT ≤ IULN
  • Renal
  • Serum creatinine \< 2.0 times IULN
  • Cardiovascular
  • No history of myocardial infarction
  • No angina pectoris
  • No known coronary artery disease
  • No history of stroke or mini-stroke (e.g., transient ischemic attack)
  • No history of thromboembolic disease (e.g., deep vein thrombosis or pulmonary embolism)
  • No uncontrolled hypertension (i.e., blood pressure \> 140/90 mmHg)
  • Pulmonary
  • No asthma after taking aspirin or other NSAIDs
  • Other
  • No known sensitivity to celecoxib
  • No allergy to sulfonamides
  • No urticaria or allergic-type reactions after taking aspirin or other NSAIDs
  • No extreme lactose intolerance
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or early bladder cancer (preinvasive transitional cell carcinoma of the bladder)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 5 years since prior biologic therapy for cancer
  • Chemotherapy
  • More than 5 years since prior chemotherapy for cancer
  • Endocrine therapy
  • At least 28 days since prior tamoxifen
  • No prior systemic estrogen modifiers (SERMs) or aromatase inhibitors
  • Concurrent hormonal contraception (i.e., pills, patches, or shots) allowed provided contraception was initiated prior to study entry
  • Radiotherapy
  • No prior radiotherapy to the breast to be studied
  • Surgery
  • Not specified
  • Other
  • At least 7 days since prior anticoagulant therapy
  • More than 1 month since prior chronic daily aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) of more than 7 days duration
  • Concurrent intermittent aspirin or NSAIDs allowed (no more than 10 days per month)
  • No concurrent participation in another clinical trial for treatment or prevention of cancer unless no longer receiving treatment and is in the follow-up phase

Exclusion

    Key Trial Info

    Start Date :

    November 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2009

    Estimated Enrollment :

    8 Patients enrolled

    Trial Details

    Trial ID

    NCT00088972

    Start Date

    November 1 2004

    End Date

    July 1 2009

    Last Update

    August 10 2018

    Active Locations (9)

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

    Page 1 of 3 (9 locations)

    1

    Glendale Memorial Hospital Comprehensive Cancer Center

    Glendale, California, United States, 91204

    2

    University of New Mexico Cancer Center

    Albuquerque, New Mexico, United States, 87131-5636

    3

    Baylor University Medical Center - Houston

    Houston, Texas, United States, 77030

    4

    Ben Taub General Hospital

    Houston, Texas, United States, 77030