- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02674204
STOP Heart Disease in Breast Cancer Survivors Trial (STOP)
1. maj 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
2
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
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Los Angeles, California, Forenede Stater, 90048
- Cedars-Sinai Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Study Agent
One atorvastatin 20 mg oral capsule per day
|
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.
Andre navne:
|
Placebo komparator: Control
One matching placebo daily
|
A substance that has no therapeutic effect, and will be used as a control in testing the study agent.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI)
Tidsramme: baseline to 12 months post initiation of statin intervention
|
baseline to 12 months post initiation of statin intervention
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in Global Longitudinal Strain as Measured by CMRI
Tidsramme: Baseline to 12 months of follow-up
|
Baseline to 12 months of follow-up
|
Change in Peak Left Ventricular Twist as Measured by CMRI
Tidsramme: Baseline to 12 months of follow-up
|
Baseline to 12 months of follow-up
|
Change in Peak Left Ventricular Torsion as Measured by CMRI
Tidsramme: Baseline to 12 months of follow-up
|
Baseline to 12 months of follow-up
|
Change in Left Ventricular Untwisting Rate as Measured by CMRI
Tidsramme: Baseline to 12 months of follow-up
|
Baseline to 12 months of follow-up
|
Change in Left Ventricular Ejection Fraction as Measured by CMRI
Tidsramme: Baseline to 12 months of follow-up
|
Baseline to 12 months of follow-up
|
Change in Left Ventricular End Diastolic Volume as Measured by CMRI
Tidsramme: Baseline to 12 months of follow-up
|
Baseline to 12 months of follow-up
|
Change in Left Ventricular End Systolic Volume as Measured by CMRI
Tidsramme: Baseline to 12 months of follow-up
|
Baseline to 12 months of follow-up
|
Change in Cardiac Output as Measured by CMRI
Tidsramme: Baseline to 12 months of follow-up
|
Baseline to 12 months of follow-up
|
Change in Left Ventricular Mass as Measured by CMRI
Tidsramme: Baseline to 12 months of follow-up
|
Baseline to 12 months of follow-up
|
Change in Left Ventricular Concentricity as Measured by CMRI
Tidsramme: Baseline to 12 months of follow-up
|
Baseline to 12 months of follow-up
|
Change in Native T1 as Measured by CMRI
Tidsramme: Baseline to 12 months of follow-up
|
Baseline to 12 months of follow-up
|
Change in Post Contrast T1 as Measured by CMRI
Tidsramme: Baseline to 12 months of follow-up
|
Baseline to 12 months of follow-up
|
Change in Extracellular Volume as Measured by CMRI
Tidsramme: Baseline to 12 months of follow-up
|
Baseline to 12 months of follow-up
|
Change in Native T2 as Measured by CMRI
Tidsramme: Baseline to 12 months of follow-up
|
Baseline to 12 months of follow-up
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Marc Goodman, PhD, Cedars-Sinal Medical Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. maj 2016
Primær færdiggørelse (Faktiske)
25. maj 2018
Studieafslutning (Faktiske)
25. maj 2018
Datoer for studieregistrering
Først indsendt
21. januar 2016
Først indsendt, der opfyldte QC-kriterier
2. februar 2016
Først opslået (Skøn)
4. februar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. maj 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. maj 2019
Sidst verificeret
1. maj 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Kemisk inducerede lidelser
- Patologiske processer
- Hjerte-kar-sygdomme
- Hudsygdomme
- Neoplasmer
- Neoplasmer efter sted
- Sår og skader
- Brystsygdomme
- Lægemiddelrelaterede bivirkninger og uønskede reaktioner
- Strålingsskader
- Hjertesygdomme
- Brystneoplasmer
- Kardiotoksicitet
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antimetabolitter
- Antikolesteræmiske midler
- Hypolipidæmiske midler
- Lipidregulerende midler
- Hydroxymethylglutaryl-CoA-reduktasehæmmere
- Atorvastatin
Andre undersøgelses-id-numre
- IIT2015-12-Goodman-STOP
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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