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Celecoxib in Preventing Breast Cancer in Premenopausal Women
This study has been completed.
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00088972
  Purpose

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 Intervention Phase
Breast Cancer
Drug: celecoxib
Drug: placebo
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control
Official Title: Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective status [ Designated as safety issue: No ]
  • Performance status [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2004
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Drug: celecoxib
Given orally
Arm II: Placebo Comparator
Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Drug: placebo
Given orally

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 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.

  • Arm I: Patients receive oral celecoxib twice daily.
  • Arm II: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 aromatose 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088972

Locations
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
Investigators
Study Chair: Powel H. Brown, MD, PhD Baylor College of Medicine
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000377698, SWOG-S0300
Study First Received: August 4, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00088972  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
breast cancer
breast cancer in situ
lobular breast carcinoma in situ
ductal breast carcinoma

Study placed in the following topic categories:
Carcinoma, Lobular
Celecoxib
Skin Diseases
Carcinoma in Situ
Breast Neoplasms
Carcinoma, Ductal, Breast
Breast Diseases
Carcinoma

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009