S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women

NCT ID: NCT00088972

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2009-07-31

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.

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.

• 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Arm I - Celecoxib

Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.

Group Type: EXPERIMENTAL

celecoxib

Intervention Type: DRUG

Given orally

Arm II - Placebo

Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Given orally

Interventions

celecoxib

Given orally

Intervention Type: DRUG

placebo

Given orally

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Powel H. Brown, MD, PhD

Role: STUDY_CHAIR

Baylor College of Medicine

Locations

Glendale Memorial Hospital Comprehensive Cancer Center

Glendale, California, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Baylor University Medical Center - Houston

Houston, Texas, United States

Ben Taub General Hospital

Houston, Texas, United States

Methodist Hospital

Houston, Texas, United States

St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital

Houston, Texas, United States

Veterans Affairs Medical Center - Houston

Houston, Texas, United States

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, United States

University Cancer Center at University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

U10CA012027

Identifier Type: NIH

Identifier Source: secondary_id

View Link

S0300

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA037429

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000377698

Identifier Type: -

Identifier Source: org_study_id