S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women
Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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California
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Glendale, California, 미국, 91204
- Glendale Memorial Hospital Comprehensive Cancer Center
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New Mexico
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Albuquerque, New Mexico, 미국, 87131-5636
- University of New Mexico Cancer Center
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Texas
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Houston, Texas, 미국, 77030
- Ben Taub General Hospital
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Houston, Texas, 미국, 77030
- Methodist Hospital
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Houston, Texas, 미국, 77030
- Veterans Affairs Medical Center - Houston
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Houston, Texas, 미국, 77030
- Baylor University Medical Center - Houston
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Houston, Texas, 미국, 77030
- St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
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Washington
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Seattle, Washington, 미국, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
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Seattle, Washington, 미국, 98195-6043
- University Cancer Center at University of Washington Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Arm I - Celecoxib
Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
|
구두로 주어진
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위약 비교기: Arm II - Placebo
Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
|
구두로 주어진
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mammographic Density
기간: 1 year
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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.
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1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Ki-67 Expression
기간: 1 year
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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).
|
1 year
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공동 작업자 및 조사자
수사관
- 연구 의자: Powel H. Brown, MD, PhD, Baylor College of Medicine
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000377698
- U10CA012027 (미국 NIH 보조금/계약)
- U10CA037429 (미국 NIH 보조금/계약)
- S0300 (기타 식별자: SWOG)
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