- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04001621
Pyrotinib in Combination With Capecitabine in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer
Phase II Study of Pyrotinib in Combination With Capecitabine in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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-
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Shanghai, Kina, 200032
- Fudan University Shanghai Cancer Center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Pathologically confirmed HER2 positive patients with locally advanced or metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification
- Aged ≥18 and ≤70 years.
- ECOG performance status of 0 to 1.
- Life expectancy of more than 12 weeks;
- At least one measurable lesion exists(RECIST 1.1)
Patients with trastuzumab resistance is defined as follows:
Progression during or within 12 months after treatment in neoadjuvant or adjuvant setting (at least 9 weeks of trastuzumab treatment); Or Progression during or within 6 months after treatment for locally advanced or metastatic disease in the first-line setting (at least 6 weeks of trastuzumab treatment).
- At least 4 weeks from the last treatment of trastuzumab or chemotherapy,at least 5 times of t1/2 or 4 weeks from the last treatment of endocrine therapy(the shorter one is preferred)
- Known hormone receptor status
- For patients with brain metastases, local treatment (including whole cranial radiotherapy, SBRT, etc.) is required and the brain lesions are stable for ≥ 3 months without the need for dexamethasone or mannitol treatment
Patients with adequate organ function before enrollment:
- ANC≥1.5×10^9/L
- PLT≥100×10^9/L
- Hb≥90 g/L
- TBIL≤1.5×ULN
- ALT and AST≤3×ULN, (ALT and AST≤5×ULN in patients with liver metastases)
- Cr≤1.5×ULN and the creatinine clearance rate≥50 mL/min
- LVEF ≥ 50%
- QTcF < 480 ms
- Signed informed consent.
Exclusion Criteria:
- Patients with meningeal metastasis and / or spinal cord metastasis;
- Patients unable to swallow, with chronic diarrhea, intestinal obstruction, or multiple factors that affect drug use and absorption;
- Patients with malignant serious effusion which cannot be controlled by drainage or other methods;
- Less than 4 weeks from the last treatment in last clinical trial;
- Known dihydropyrimidine dehydrogenase (DPD) deficiency;
- Receiving any other antitumor therapy;
- History of other malignancy within the last 5 years, except for carcinoma in situ of cervix, basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent;
- Received radiotherapy, surgery (excluding local puncture) within 4 weeks prior to enrollment; received anti-tumor endocrine therapy after entering the screening period;
- Previous or ongoing use of HER2-targeted tyrosine kinase inhibitors (lapatinib, neratinib or pyrotinib);
- Previous use of capecitabine or capecitabine not tolerated, except that capecitabine efficacy cannot be judged or capecitabine discontinuation for 3 months or more;
- Patients with serious heart disease;
- Allergy to pyrotinib; history of immunodeficiency, including HIV positive, active HBV/HCV or other acquired, congenital immunodeficiency disease, or organ transplantation history;
- Known history of neurological or psychiatric disease, including epilepsy or dementia;
- Patients during pregnancy or lactation, patients with childbearing potential tested positive in baseline pregnancy test, or patients unwilling to take effective contraceptive measures throughout the trial;
- Evidence of significant medical illness that will substantially increase the risk on the participation or completion of the study in the investigator's judgment. Examples included, but not limited to, hypertension, severe diabetes, etc;
- Patients not eligible for this study judged by the investigator.
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: Pyrotinib plus capecitabine
pyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)
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pyrotinib 400 mg once daily; Capecitabine 1000 mg/m2 per day on day 1 through 14, every 21 days.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Progressionsfri overlevelse (PFS)
Tidsramme: Anslået 12 måneder
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Fra tilmelding til progression eller død (uanset grund)
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Anslået 12 måneder
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Objektiv responsrate (ORR)
Tidsramme: Anslået 12 måneder
|
Forholdet mellem CR og PR i alle fag
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Anslået 12 måneder
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Varighed af svar (DOR)
Tidsramme: Anslået 12 måneder
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Den første evaluering af CR eller PR til progression eller død (uanset grund)
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Anslået 12 måneder
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Clinical Benefit rate (CBR)
Tidsramme: Anslået 12 måneder
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Forholdet mellem CR, PR og SD større end eller lig med 24 uger i alle forsøgspersoner
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Anslået 12 måneder
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Samlet overlevelse (OS)
Tidsramme: Estimeret 24 måneder
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Fra indskrivning til død (uanset grund)
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Estimeret 24 måneder
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Uønskede hændelser og alvorlige bivirkninger
Tidsramme: Fra informeret samtykke til 28 dage efter afsluttet behandling
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Sikkerhed
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Fra informeret samtykke til 28 dage efter afsluttet behandling
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Xichun Hu, Department of Oncology
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 (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HR-BLTN-003
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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