S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women
This study has been terminated.
(Study closed due to poor accrual.)
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00088972
First received: August 4, 2004
Last updated: February 27, 2013
Last verified: February 2013
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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 Other: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Celecoxib
U.S. FDA Resources
Further study details as provided by Southwest Oncology Group:
Primary Outcome Measures:
- Mammographic Density [ Time Frame: 1 year ] [ Designated as safety issue: No ]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:
- Ki-67 Expression [ Time Frame: 1 year ] [ Designated as safety issue: No ]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).
| Enrollment: | 8 |
| Study Start Date: | November 2004 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
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 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
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
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00088972 History of Changes |
| Other Study ID Numbers: | CDR0000377698, U10CA012027, S0300, U10CA037429 |
| Study First Received: | August 4, 2004 |
| Results First Received: | November 9, 2012 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 Neoplasms Breast Diseases Skin Diseases Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013