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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
California
-
Glendale、California、アメリカ、91204
- Glendale Memorial Hospital Comprehensive Cancer Center
-
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New Mexico
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Albuquerque、New Mexico、アメリカ、87131-5636
- University of New Mexico Cancer Center
-
-
Texas
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Houston、Texas、アメリカ、77030
- Ben Taub General Hospital
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Houston、Texas、アメリカ、77030
- Methodist Hospital
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Houston、Texas、アメリカ、77030
- Veterans Affairs Medical Center - Houston
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Houston、Texas、アメリカ、77030
- Baylor University Medical Center - Houston
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Houston、Texas、アメリカ、77030
- St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
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Washington
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Seattle、Washington、アメリカ、98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
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Seattle、Washington、アメリカ、98195-6043
- University Cancer Center at University of Washington Medical Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm I - Celecoxib
Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
|
経口投与
|
|
プラセボコンパレーター：Arm II - Placebo
Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
|
経口投与
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mammographic Density
時間枠：1 year
|
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.
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Ki-67 Expression
時間枠：1 year
|
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
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Powel H. Brown, MD, PhD、Baylor College of Medicine
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000377698
- U10CA012027 (米国 NIH グラント/契約)
- U10CA037429 (米国 NIH グラント/契約)
- S0300 (その他の識別子：SWOG)
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