S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00088972
Recruitment Status : Terminated (Study closed due to poor accrual.)
First Posted : August 5, 2004
Results First Posted : April 9, 2013
Last Update Posted : August 10, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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: This randomized phase II trial is studying how well celecoxib works in preventing breast cancer in premenopausal women who are at risk for developing the disease.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: celecoxib Other: placebo Phase 2

Detailed Description:


  • 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 epithelial cells, as measured by Ki67 staining, in patients treated with these drugs.
  • Compare the expression of other biomarkers, including cyclo-oxygenase-2 (COX-2) enzyme and a marker of apoptosis, in breast tissue of patients treated with these drugs.
  • Compare 1-year plasma levels of insulin-like growth factor (IGF)-1, IGF binding protein-3, and prostaglandin E_2 in patients treated with these drugs.
  • Compare the toxicity of these drugs in these patients.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to risk category (lobular carcinoma in situ or ductal carcinoma in situ vs BRCA1/2 mutation AND any Gail risk vs Gail risk ≥1.7% but < 5% vs Gail risk ≥ 5%) and prior tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Celocoxib: Patients receive oral celecoxib twice daily.
  • Placebo: Patients receive oral placebo twice daily. In both arms, treatment continues for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer
Study Start Date : November 2004
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Arm I - Celecoxib
Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Drug: celecoxib
Given orally

Placebo Comparator: Arm II - Placebo
Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Other: placebo
Given orally

Primary Outcome Measures :
  1. Mammographic Density [ Time Frame: 1 year ]
    The primary outcome measure is change in mammographic density. The null hypothesis is that there is no difference between the arms in change in mammographic density over one year versus the alternative that the treatment arm reduces mammographic density by 10 points (percent of pixels highlighted) or more over one year compared to the change in the placebo arm.

Secondary Outcome Measures :
  1. Ki-67 Expression [ Time Frame: 1 year ]
    The difference between the two arms in the percent of patients with non-zero ki-67 expression over the two time periods (baseline and 1-year).

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over


  • 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


  • Not specified


  • 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


  • Serum creatinine < 2.0 times IULN


  • 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)


  • No asthma after taking aspirin or other NSAIDs


  • 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


Biologic therapy

  • More than 5 years since prior biologic therapy for cancer


  • 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


  • No prior radiotherapy to the breast to be studied


  • Not specified


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00088972

United States, California
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, United States, 91204
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, Texas
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030
Ben Taub General Hospital
Houston, Texas, United States, 77030
Methodist Hospital
Houston, Texas, United States, 77030
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
Veterans Affairs Medical Center - Houston
Houston, Texas, United States, 77030
United States, Washington
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Powel H. Brown, MD, PhD Baylor College of Medicine

Responsible Party: Southwest Oncology Group Identifier: NCT00088972     History of Changes
Other Study ID Numbers: CDR0000377698
U10CA012027 ( U.S. NIH Grant/Contract )
S0300 ( Other Identifier: SWOG )
U10CA037429 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2004    Key Record Dates
Results First Posted: April 9, 2013
Last Update Posted: August 10, 2018
Last Verified: July 2018

Keywords provided by Southwest Oncology Group:
breast cancer
breast cancer in situ
lobular breast carcinoma in situ
ductal breast carcinoma

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents