STOP Heart Disease in Breast Cancer Survivors Trial (STOP)
2019年5月1日 更新者：Marc Goodman、Cedars-Sinai Medical Center
Statin Therapy Operates to Prevent (STOP) Heart Disease in Breast Cancer Survivors Trial
The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on changes to the heart among women undergoing breast cancer treatment.
Atorvastatin may reduce or eliminate the harmful effects of chemotherapy treatment to the heart tissue of breast cancer patients.
調査の概要
詳細な説明
This is a placebo-controlled study.
It will compare the effects of atorvastatin against the effects of a placebo (an inactive substance, such as, a sugar pill) on changes to the heart before and during breast cancer treatment.
Participants will be in the study for approximately a year and a half, and the study will enroll up to 60 patients.
During that time, there will be six visits that may coincide with standard of care visits.
Participants will also receive telephone calls from study staff during the study intervention and a follow-up phase to check-in with them.
研究の種類
介入
入学 (実際)
2
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Los Angeles、California、アメリカ、90048
- Cedars-Sinai Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- Female patients with newly diagnosed stage 1-3 breast cancer
- Histologically confirmed HER2, ER, and PR status
- Recommended to undergo trastuzumab treatment, with or without anthracycline. Patients will be eligible for up to 3 weeks after starting treatment.
- Age minimum 18 years
- Able and willing to read, understand, and sign an informed consent form (ICF) and medical release form
- Willing and able to comply with trial protocol and follow-up
- ECOG performance status 0-1 (Karnofsky ≥ 70%)
Exclusion Criteria:
- Prior use of statin medication within the past year
- Not using statin medication but is eligible for statin therapy based on the 2013 ACC/AHA guidelines (LDL cholesterol >190, or LDL <190 and ASCVD risk >7.5%; http://tools.acc.org/ASCVD-Risk-Estimator/) and is > 50 years old; or is eligible for statin therapy based on the 2013 ACC/AHA guidelines and is 40-50 years old and wishes to be placed on statin therapy
- History of adverse effects, intolerance, or allergic reactions attributed to statin medication
- Current use of gemfibrozil, cyclosporine, clarithromycin, itraconazole, erythromycin, the hepatitis C protease inhibitor telaprevir, HIV protease inhibitors, colchicine, or red yeast rice
- Current use of any other investigational agent
- Pregnant or intention to get pregnant during the next 18 months. Pregnant women are excluded from this study because atorvastatin is a lipid-lowering agent with the potential for teratogenic or abortifacient effects, and MRI is contraindicated in pregnant women.
- History of diabetes, severe lung disease, renal disease (creatinine > 1.8 mg/dL or CrCl ≤ 50 mL/min), or hepatic disease (AST and ALT > 3 times upper normal limits)
- Abnormal baseline echocardiogram or cardiac MRI (detection of congenital heart disease; ischemic heart disease; moderate or severe valvular heart disease; cardiomyopathy; EF < 55%)
- Previously known or diagnosed heart disease (e.g. congenital; valvular; coronary artery disease; history of myocardial infarction or acute coronary syndrome; cardiomyopathy, including infiltrative, hypertensive, hypertrophic, dilated, constrictive pericarditis, or other cardiomyopathy)
- Left ventricular dysfunction (EF < 55%)
- Prior non-cardiac illness with an estimated life expectancy < 4 years
- Known active infection with HIV
- Allergy or contraindication to MRI testing, including claustrophobia, metallic parts in body the prohibiting MRI, prior gadolinium contrast reaction, or uncontrolled moderate hypertension (sitting blood pressure >160/95 mm Hg with measurements recorded on at least 2 occasions).
- Has metallic breast expanders in place at the time of screening
- Concurrent illness which in the opinion of the investigators would compromise either the patient or the integrity of the data
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：処理
- 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 |
|---|---|
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実験的：Study Agent
One atorvastatin 20 mg oral capsule per day
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Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.
This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.
他の名前：
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プラセボコンパレーター：Control
One matching placebo daily
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A substance that has no therapeutic effect, and will be used as a control in testing the study agent.
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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 |
時間枠 |
|---|---|
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Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI)
時間枠：baseline to 12 months post initiation of statin intervention
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baseline to 12 months post initiation of statin intervention
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Change in Global Longitudinal Strain as Measured by CMRI
時間枠：Baseline to 12 months of follow-up
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Baseline to 12 months of follow-up
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Change in Peak Left Ventricular Twist as Measured by CMRI
時間枠：Baseline to 12 months of follow-up
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Baseline to 12 months of follow-up
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Change in Peak Left Ventricular Torsion as Measured by CMRI
時間枠：Baseline to 12 months of follow-up
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Baseline to 12 months of follow-up
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Change in Left Ventricular Untwisting Rate as Measured by CMRI
時間枠：Baseline to 12 months of follow-up
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Baseline to 12 months of follow-up
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Change in Left Ventricular Ejection Fraction as Measured by CMRI
時間枠：Baseline to 12 months of follow-up
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Baseline to 12 months of follow-up
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Change in Left Ventricular End Diastolic Volume as Measured by CMRI
時間枠：Baseline to 12 months of follow-up
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Baseline to 12 months of follow-up
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Change in Left Ventricular End Systolic Volume as Measured by CMRI
時間枠：Baseline to 12 months of follow-up
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Baseline to 12 months of follow-up
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Change in Cardiac Output as Measured by CMRI
時間枠：Baseline to 12 months of follow-up
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Baseline to 12 months of follow-up
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Change in Left Ventricular Mass as Measured by CMRI
時間枠：Baseline to 12 months of follow-up
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Baseline to 12 months of follow-up
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Change in Left Ventricular Concentricity as Measured by CMRI
時間枠：Baseline to 12 months of follow-up
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Baseline to 12 months of follow-up
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Change in Native T1 as Measured by CMRI
時間枠：Baseline to 12 months of follow-up
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Baseline to 12 months of follow-up
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Change in Post Contrast T1 as Measured by CMRI
時間枠：Baseline to 12 months of follow-up
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Baseline to 12 months of follow-up
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Change in Extracellular Volume as Measured by CMRI
時間枠：Baseline to 12 months of follow-up
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Baseline to 12 months of follow-up
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Change in Native T2 as Measured by CMRI
時間枠：Baseline to 12 months of follow-up
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Baseline to 12 months of follow-up
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Marc Goodman, PhD、Cedars-Sinal Medical Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年5月5日
一次修了 (実際)
2018年5月25日
研究の完了 (実際)
2018年5月25日
試験登録日
最初に提出
2016年1月21日
QC基準を満たした最初の提出物
2016年2月2日
最初の投稿 (見積もり)
2016年2月4日
学習記録の更新
投稿された最後の更新 (実際)
2019年5月15日
QC基準を満たした最後の更新が送信されました
2019年5月1日
最終確認日
2019年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IIT2015-12-Goodman-STOP
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。