- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05047848
Clinical Study of Chidamide Combined With Fulvestrant in the Treatment of Hormone Receptor-positive Advanced Breast Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Sun Tao, Doctor
- Telefonnummer: 13940404526
- E-mail: lnzlrxnsy@163.com
Studiesteder
-
-
Liaoning
-
Shenyang, Liaoning, Kina, 110042
- Rekruttering
- Liangning Tumor Hospital &Institute
-
Kontakt:
- Sun Tao, Doctor
- Telefonnummer: 13940404526
- E-mail: lnzlrxnsy@163.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- women aged ≥ 18 years, histologically or cytologically confirmed HR positive (ER expression ≥ 10%, PR positive or negative), HER2 negative breast cancer patients;
- before enrollment for unresectable locally advanced or metastatic breast cancer, and at least one measurable lesion or no measurable lesion and bone metastasis alone patients;
For locally advanced or metastatic breast cancer, no previous endocrine therapy or first-line endocrine therapy, and no previous use of CDK4/6 inhibitors. Specifically, it includes the following conditions:
Cohort 1: (neo) recurrence > 12 months after the end of adjuvant endocrine therapy, and without any rescue therapy · newly diagnosed advanced breast cancer without any rescue therapy Cohort 2: (neo) recurrence during or ≤ 12 months after the completion of adjuvant endocrine therapy, and without any rescue therapy · recurrence > 12 months after the completion of adjuvant endocrine therapy, and progression by first-line endocrine therapy · newly diagnosed advanced breast cancer and progression by first-line endocrine rescue therapy
- Cohort 1 without previous chemotherapy for advanced breast cancer; Cohort 2 with ≤ 1 previous chemotherapy for advanced breast cancer;
- no brain metastasis or asymptomatic brain metastasis;
- ECOG score 0-1;
- Absolute neutrophil count ≥ 1.5 × 109/L, platelet ≥ 100 × 109/L, hemoglobin ≥ 90 g/L;
- Expected survival time ≥ 3 months;
- Voluntarily participate in this clinical trial, sign the written informed consent;
Exclusion Criteria:
- no measurable lesions (except bone metastases alone), such as pleural or pericardial exudates, ascites, etc.
- Patients who have undergone major surgical procedures or significant trauma before enrollment, or are expected to undergo major surgical treatment
- Patients who have previously been treated with CDK4/6 inhibitors, fulvestrant or HDAC inhibitors (including romidepsin, vorinostat, berlistat, parabrestat), but have received 1 cycle (≤ 2 times, on d1, d15, respectively) of fulvestrant within 28 days (before enrollment) are allowed
- Known history of allergy to the drug components of this protocol
- Meningeal metastasis before enrollment
- Uncontrollable serosal effusion
- Active infection [an active bacterial, viral, fungal, mycobacterial, parasitic or other infection (excluding fungal infections of the nail bed) within 4 months prior to Screening or any major infectious event requiring intravenous antibiotics, or targeted antiviral therapy, or hospitalization], or persistent fever within 14 days prior to Screening
- a history of immunodeficiency, including HIV test positive, or suffering from other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
- according to the investigator's judgment, there are serious hazards to the patient's safety, or affect the patient to complete the study of concomitant diseases (such as: severe hypertension, diabetes, thyroid disease, active infection, etc.);
- History of definite neurological or psychiatric disorders, including epilepsy or dementia
- Subjects who, in the opinion of the investigator, are not suitable for the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: chidamid + fulvestrant
|
chidamide 30mg orally,Biw
Fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Samlet responsrate (ORR)
Tidsramme: Op til cirka 26 måneder
|
Samlet responsrate (ORR) er defineret som andelen af patienter med det bedste samlede respons af fuldstændig respons (CR) eller delvis respons (PR) i henhold til RECIST 1.1.
|
Op til cirka 26 måneder
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Samlet overlevelse (OS)
Tidsramme: Op til cirka 58 måneder
|
Tid fra dato for randomisering til dato for død uanset årsag.
|
Op til cirka 58 måneder
|
Progression Free Survival (PFS)
Tidsramme: Up to approximately 26 months
|
PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause.
|
Up to approximately 26 months
|
Clinical Benefit Rate (CBR)
Tidsramme: Up to approximately 26 months
|
Clinical benefit rate (CBR), defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1.
|
Up to approximately 26 months
|
Duration of Response (DOR)
Tidsramme: Up to approximately 26 months
|
Time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer as defined in RECIST 1.1.
|
Up to approximately 26 months
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hudsygdomme
- Neoplasmer
- Neoplasmer efter sted
- Brystsygdomme
- Brystneoplasmer
- Lægemidlers fysiologiske virkninger
- Antineoplastiske midler
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Hormonantagonister
- Østrogenantagonister
- Østrogenreceptorantagonister
- Fulvestrant
Andre undersøgelses-id-numre
- CSIIT-C18
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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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