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Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer


- 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

Inclusion Criteria


- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Mammographic Density

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Powel H. Brown, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Baylor College of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

November 2004

Completion Date:

July 2009

Related Keywords:

  • Breast Cancer
  • breast cancer
  • breast cancer in situ
  • lobular breast carcinoma in situ
  • ductal breast carcinoma
  • Breast Neoplasms



Veterans Affairs Medical Center - Houston Houston, Texas  77030
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Baylor University Medical Center - Houston Houston, Texas  77030-2399
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Ben Taub General Hospital Houston, Texas  77030
Methodist Hospital Houston, Texas  77030
Glendale Memorial Hospital Comprehensive Cancer Center Glendale, California  91204
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital Houston, Texas  77030