- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02416427
Targeting the Hippo Transducer TAZ in Breast Cancer With Statins (TRINACRIA)
9. april 2015 opdateret af: Dr. Marcello Maugeri-Saccà, Regina Elena Cancer Institute
A Phase II, Randomized, Non-comparative, Pre-surgical Study of Atorvastatin or Observation in Ki-67 Positive, TAZ-expressing Early Breast Cancer Patients (TRINACRIA Trial)
This pre-surgical, window-of-opportunity study is designed to investigate whether atorvastatin reduces the proliferation marker Ki-67 via modulation of the Hippo transducer TAZ.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
78
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Marcello Maugeri Saccà, MD
- Telefonnummer: 2724 +39065266
- E-mail: maugeri@ifo.it
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 til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion:
- Signed written informed consent
- Female aged >18 years and <75 years at the time of the enrolment
- Histologically confirmed Breast Cancer (BC) independently on the intrinsic subtype
- Stage I-IIa BC patients candidate for elective surgery
- BC expressing Ki-67 ≥ 15% and TAZ > 10% in diagnostic core biopsies
- Adequate baseline organ function
- Negative pregnancy test
Exclusion:
- Previous systemic therapy including chemotherapy, hormone therapy and targeted agents
- Administration of an investigational drug prior to enrolment
- History of another malignancy, except for a history of completely resected non-melanoma skin cancer or successfully treated cervical in situ carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status ≥2
- Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome and asymptomatic gallstones)
- Serious cardiac illness or medical conditions including but not confined to: history of documented congestive heart failure (CHF) or systolic dysfunction (LVEF <50%); high-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately controlled); angina pectoris requiring antianginal medication; clinically significant valvular heart disease; evidence of transmural infarction on ECG; poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic >100mm Hg)
- Have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent)
- Current or recent therapy with statins for hypercholesterolemia or other lipid-lowering drugs
- Current or recent therapy with glucose-lowering drugs for diabetes
- Current or recent therapy with strong CYP3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, itraconazole) given potential interactions with atorvastatin
- Current or recent therapy with gemfibrozil or other fibrates given potential interactions with atorvastatin.
- Patients who are pregnant or breastfeeding
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Arm A
Atorvastatin 80 mg/day for 3 weeks
|
Atorvastatin will be administered at 80 mg/day for 3 weeks in the time window between diagnostic biopsy and curative surgery
|
Ingen indgriben: Arm B
Observation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Ki-67 reduction below the 15% (marker response).
Tidsramme: 4 weeks
|
4 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
• Decreased TAZ expression
Tidsramme: 4 weeks
|
Reduced TAZ expression evaluated by IHC when comparing pre- and post-treatment samples.
Staining intensity will be graded on a four-grade scale (0: negative, 1: weak, 2: moderate, 3: strong).
The final score will be obtained by considering staining intensity, percentage of expressing cells, and localization (nuclear versus cytoplasmic)
|
4 weeks
|
Pathway inhibition
Tidsramme: 4 weeks
|
Decreased expression of TAZ targets (AXL and CTGF) and Atorvastatin target (HMGCoAR) evaluated by IHC when comparing pre- and post-treatment samples.
Staining intensity for all the molecular endpoints analyzed will be graded on a four-grade scale (0: negative, 1: weak, 2: moderate, 3: strong).
|
4 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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
1. maj 2015
Primær færdiggørelse (Forventet)
1. december 2016
Studieafslutning (Forventet)
1. december 2016
Datoer for studieregistrering
Først indsendt
2. april 2015
Først indsendt, der opfyldte QC-kriterier
9. april 2015
Først opslået (Skøn)
15. april 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. april 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. april 2015
Sidst verificeret
1. april 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 637/15
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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