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Study of Cipterbin®, Used Alone or With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer

21. september 2011 opdateret af: Shanghai CP Guojian Pharmaceutical Co., Ltd.

An Open-Label Randomized Phase II Study of Cipterbin® or Cipterbin® in Combination With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer (MBC)

The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a humanized anti-HER2/neu receptor monoclonal antibody, has been proved a valuable treatment for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has been shown to increase both survival and response rate, in comparison to trastuzumab alone. CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical Co.Ltd. Efficacy and safety of CMAB302 as a single agent or in combination with vinorelbine were evaluated in patients with HER2-overexpressing metastatic breast cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a humanized anti-HER2/neu receptor monoclonal antibody, has been proved valuable treatment for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has been shown to increase both survival and response rate, in comparison to trastuzumab alone. CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical Co.Ltd. Previous Phase I study showed that CMAB302 was well tolerated as monotherapy and the pharmacokinetic data exhibited a non-linear profile over the dose range of 100 to 500 mg, similar to that of trastuzumab. In this study, efficacy and safety of CMAB302 as a single agent or in combination with vinorelbine were evaluated in patients with HER2-overexpressing metastatic breast cancer.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

109

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Beijing, Kina, 100021
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • pathologic diagnosis breast cancer
  • HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1 measurable lesion as per RECIST criteria
  • Adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
  • Adequate liver (bilirubin <1.0 times upper limit of normal and SGOT/SGPT <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
  • Adequate cardiac function (LVEF>50%). Normal electrocardiogram and absence of significant heart disease
  • age from 18 to 70y
  • Karnofsky performance score ≥ 60
  • Life expectancy of greater than 3 months
  • Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.
  • signed ICF

Exclusion Criteria:

  • prior exposure vinorelbine for breast cancer
  • prior exposure trastuzumab for breast cancer
  • Prior chemotherapy and radiation therapy within the last 4 weeks before enrollment
  • use of any other investigational agents within the last 4 weeks before enrollment
  • symptomatic, central nervous system metastases
  • Hypersensitivity to trial medications
  • breastfeeding or pregnant

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: combination agent group
Medicin: humanized anti-HER2 antibody
Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly for 12 weeks. For single agent group, patients with complete response, partial response or stable disease could be treated for 24 weeks.
Andre navne:
  • brand name:Cipterbin®
Medicin: Vinorelbine
Vinorelbine was administered weekly at a dose of 25 mg/m2 on day 1, 8 and 21 every 4 weeks
Andre navne:
  • brand name:NAVELBINE®
Eksperimentel: single agent group
In this arm, patients would be treated with Cipterbin® for 12 or 24 weeks
Medicin: humanized anti-HER2 antibody
Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly for 12 weeks. For single agent group, patients with complete response, partial response or stable disease could be treated for 24 weeks.
Andre navne:
  • brand name:Cipterbin®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall response rate
Tidsramme: up to 24 weeks
according to RECIST 1.0 (Response Evaluation Criteria In Solid Tumors)
up to 24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
One-year survival rate
Tidsramme: 1 year
1 year
Number of participants with adverse events
Tidsramme: up to 24 weeks
Adverse events was recorded according to NCI CTC 2.0 (National Cancer Institute common toxicity criteria).
up to 24 weeks
Overall control of disease
Tidsramme: up to 24 weeks
defined as overall response rate plus stable disease, by RECIST 1.0
up to 24 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai CP Guojian Pharmaceutical Co., Ltd.

Efterforskere

  • Studiestol: Yan Sun, PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Studieleder: Yuankai Shi, PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Ledende efterforsker: Zefei Jiang, PhD, Hospital Affiliated to Academy Military Medical Science
  • Ledende efterforsker: Jun Ren, PhD, Peking University Cancer Hospital & Institute
  • Ledende efterforsker: Kai Li, PhD, Tianjin Medical University Cancer Institute and Hospital
  • Ledende efterforsker: Dong Wang, PhD, Daping Hospital & Research Institute of Surgery of the Third Military Medical University

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. juli 2005

Primær færdiggørelse (Faktiske)

1. februar 2007

Studieafslutning (Faktiske)

1. maj 2007

Datoer for studieregistrering

Først indsendt

21. september 2011

Først indsendt, der opfyldte QC-kriterier

21. september 2011

Først opslået (Skøn)

23. september 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. september 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. september 2011

Sidst verificeret

1. juni 2005

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C302MBCⅡ

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Kliniske forsøg med Metastatisk brystkræft

Kliniske forsøg med humanized anti-HER2 antibody

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