- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02674204
STOP Heart Disease in Breast Cancer Survivors Trial (STOP)
1. mai 2019 oppdatert av: 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.
Studieoversikt
Status
Avsluttet
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
2
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
Los Angeles, California, Forente stater, 90048
- Cedars-Sinai Medical Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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 navn:
|
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.
|
Hva måler studien?
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Marc Goodman, PhD, Cedars-Sinal Medical Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
5. mai 2016
Primær fullføring (Faktiske)
25. mai 2018
Studiet fullført (Faktiske)
25. mai 2018
Datoer for studieregistrering
Først innsendt
21. januar 2016
Først innsendt som oppfylte QC-kriteriene
2. februar 2016
Først lagt ut (Anslag)
4. februar 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. mai 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. mai 2019
Sist bekreftet
1. mai 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Kjemisk-induserte lidelser
- Patologiske prosesser
- Kardiovaskulære sykdommer
- Hudsykdommer
- Neoplasmer
- Neoplasmer etter nettsted
- Sår og skader
- Bryst sykdommer
- Legemiddelrelaterte bivirkninger og uønskede reaksjoner
- Strålingsskader
- Hjertesykdommer
- Brystneoplasmer
- Kardiotoksisitet
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antimetabolitter
- Antikolesteremiske midler
- Hypolipidemiske midler
- Lipidregulerende midler
- Hydroksymetylglutaryl-CoA-reduktasehemmere
- Atorvastatin
Andre studie-ID-numre
- IIT2015-12-Goodman-STOP
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Brystkreft
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital og andre samarbeidspartnereFullførtThe Clinical Application Guide of Conebeam Breast CTKina
-
Novartis PharmaceuticalsFullførtMetastatisk brystkreft (MBC) | Locally Advance Breast Cancer (LABC)Storbritannia, Spania
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UkjentHR-positiv, HER2-negativ og PIK3CA Mutation Advanced Breast CancerKina
-
Emory UniversityNational Cancer Institute (NCI)TilbaketrukketPrognostisk stadium IV brystkreft AJCC v8 | Metastatisk malign neoplasma i hjernen | Metastatisk brystkarsinom | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
NRG OncologyNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeAnatomisk stadium IV brystkreft AJCC v8 | Prognostisk stadium IV brystkreft AJCC v8 | Metastatisk malign neoplasma i beinet | Metastatisk malign neoplasma i lymfeknutene | Metastatisk malign neoplasma i leveren | Metastatisk brystkarsinom | Metastatisk malign neoplasma i lungen | Metastatisk malign neoplasma... og andre forholdForente stater, Canada, Saudi-Arabia, Korea, Republikken
Kliniske studier på Atorvastatin
-
GlaxoSmithKlineFullførtDiabetes mellitus, type 2Korea, Republikken, Malaysia, Filippinene, Thailand, Den russiske føderasjonen, Mexico
-
Chong Kun Dang PharmaceuticalFullførtHøyt kolesterolKorea, Republikken
-
Obafemi Awolowo University Teaching HospitalOpen PhilanthropyRekruttering
-
Organon and CoFullført
-
Tanta UniversityFullført
-
Hippocration General HospitalFullførtKoronararteriesykdom | Aterosklerose | Endotelial dysfunksjon | Oksidativt stress | HMG-CoA-reduktasehemmer toksisitetHellas
-
PfizerFullførtHypertriglyseridemi | Hyperlipoproteinemi Type IVForente stater, Canada
-
St. Olavs HospitalUllevaal University Hospital; Oslo University Hospital; University Hospital... og andre samarbeidspartnereHar ikke rekruttert ennå
-
Beijing HospitalUkjent
-
Zhongda HospitalHar ikke rekruttert ennåAkutt iskemisk hjerneslag | Mekanisk trombektomiKina