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An Efficacy Study of Trabectedin in the Treatment of Participants With Specific Subtypes of Metastatic Breast Cancer

24. februar 2014 oppdatert av: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Phase II, Multicenter, Open-label, Clinical Trial of Trabectedin (Yondelis) in Metastatic Breast Cancer Patients With Triple Negative Profile (ER-, PR-, HER2-), HER2 Overexpressing Tumors and BRCA1 or BRCA2 Mutation Carriers

The purpose of this study is to evaluate the effectiveness and safety of trabectedin in 3 subpopulations of participants with previously treated progressive metastatic ( spread of a cancer from one organ or part to another non-adjacent organ or part) breast cancer (abnormal tissue that grows and spreads in the body until it kills) participants.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multi-center (when more than 1 hospital or medical school team work on a medical research study) study evaluating the effectiveness and safety of trabectedin in 3 subpopulations of breast cancer participants: Group A: triple negative profile for estrogen receptor, progesterone receptor and human estrogen receptor, Group B: human epidermal growth factor receptor-2 overexpressing tumors (HER-2+) and Group C: familial breast cancer gene 1 (BRCA1) or breast cancer gene 2 (BRCA2) mutation carrier. Participants will receive trabectedin 1.3 milligram per square meter (mg/m^2) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over 3-hour every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks. Treatment will be continued until disease progression, unmanageable toxicity, participant refusal or treatment delay no longer than 3 weeks due to toxicity. Efficacy will be primarily evaluated by percentage of participants with confirmed objective response by independent external review and Investigators assessment. Participants' safety will be monitored throughout the study.

Studietype

Intervensjonell

Registrering (Faktiske)

127

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Sedona, Arizona, Forente stater
    • Colorado
      • Denver, Colorado, Forente stater
    • Connecticut
      • Torrington, Connecticut, Forente stater
    • Indiana
      • Indianapolis, Indiana, Forente stater
    • Maryland
      • Westminster, Maryland, Forente stater
    • Minnesota
      • Minneapolis, Minnesota, Forente stater
    • Missouri
      • Columbia, Missouri, Forente stater
      • Kansas City, Missouri, Forente stater
      • St. Louis, Missouri, Forente stater
    • New York
      • Amsterdam, New York, Forente stater
      • New York, New York, Forente stater
    • Texas
      • Bedford, Texas, Forente stater
      • Dallas, Texas, Forente stater
      • Houston, Texas, Forente stater
      • San Antonio, Texas, Forente stater
      • Tyler, Texas, Forente stater
    • Virginia
      • Norfolk, Virginia, Forente stater
      • Salem, Virginia, Forente stater
    • Washington
      • Seattle, Washington, Forente stater
      • Spokane, Washington, Forente stater
      • Yakima, Washington, Forente stater
  • Frankrike
      • Bourdeaux, Frankrike
      • Marseille, Frankrike
      • Saint Herblain, Frankrike
      • Strasbourg Cedex, Frankrike
      • Villejuif, Frankrike
  • Israel
      • Jerusalem, Israel
      • Rehovot, Israel
      • Tel Hashomer, Israel
      • Tel-Aviv, Israel
  • Polen
      • Lubin, Polen
      • Rybnik, Polen
      • Szczecin, Polen

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

Alle

Beskrivelse

Inclusion Criteria:

  • Participants with histologically proven diagnosis of progressive metastatic breast cancer
  • Participants with measurable disease as per the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines
  • Participants with bone metastases currently receiving bisphosphonates for palliation will be eligible if other sites of measurable disease are present
  • Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 and adequately recovered from the acute toxicity of any prior treatment
  • Participants with serum creatinine less than or equal to 1.5 milligram per deciliter (mg/dl) or creatinine clearance greater than or equal to 30 milliliter per minute (ml/min)

Exclusion Criteria:

  • Participants with previous exposure to trabectedin
  • Participants with more than 3 previous chemotherapy regimens for metastatic disease and known hypersensitivity to components of trabectedin intravenous formulation or dexamethasone
  • Pregnant or lactating women or any women of childbearing potential who is not employing adequate contraception
  • Completion of previous therapy : Less than 2 weeks from radiation therapy or last dose of hormonal therapy, less than 3 weeks from previous biological therapy or chemotherapy
  • Participants with known leptomeningeal disease and other serious illnesses like congestive heart failure or angina pectoris; myocardial infarction within 1 year before enrolment; uncontrolled arterial hypertension or arrhythmias or active infection or psychiatric disorder or active viral hepatitis

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: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Group A
Participants with triple negative phenotype: estrogen receptor, progesterone receptor and human estrogen receptor-2 (HER-2) negative status for breast cancer (abnormal tissue that grows and spreads in the body until it kills) will receive trabectedin 1.3 milligram per meter square (mg/m^2) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over 3-hours (hrs) every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks. Treatment will be continued until disease progression, unmanageable toxicity, participant refusal or treatment delay no longer than 3 weeks due to toxicity. Along with study drug participants will be given dexamethasone 4 milligram (mg) orally 24 hrs and 12hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72hrs after the start of study drug infusion from Day 1 to 3.
Legemiddel: Dexamethasone
Dexamethasone 4 mg orally 24 hrs and 12 hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion on Day 1 to 3.
Legemiddel: Trabectedin
Trabectedin 1.3 mg/m^2 intravenous infusion over 3-hrs every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks.
Andre navn:
  • Yondelis
Eksperimentell: Group B
Participants with overexpressing HER-2 breast cancer will receive trabectedin 1.3 mg/m^2 intravenous infusion over 3-hrs every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks. Treatment will be continued until disease progression, unmanageable toxicity, participant refusal or treatment delay no longer than 3 weeks due to toxicity. Along with study drug participants will be given dexamethasone 4 milligram (mg) orally 24 hrs and 12hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion from Day 1 to 3.
Legemiddel: Dexamethasone
Dexamethasone 4 mg orally 24 hrs and 12 hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion on Day 1 to 3.
Legemiddel: Trabectedin
Trabectedin 1.3 mg/m^2 intravenous infusion over 3-hrs every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks.
Andre navn:
  • Yondelis
Eksperimentell: Group C
Participants with familial breast cancer gene 1 (BRCA1) or breast cancer gene 2 (BRCA2) mutation carriers cancer will receive trabectedin 1.3 mg/m^2 intravenous infusion over 3-hrs every 3 weeks on Day 1 of each cycle. Each cycle length will be 3 weeks. Treatment will be continued until disease progression, unmanageable toxicity, participant refusal or treatment delay no longer than 3 weeks due to toxicity. Along with study drug participants will be given dexamethasone 4 mg orally 24 hrs and 12hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion from Day 1 to 3.
Legemiddel: Dexamethasone
Dexamethasone 4 mg orally 24 hrs and 12 hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion on Day 1 to 3.
Legemiddel: Trabectedin
Trabectedin 1.3 mg/m^2 intravenous infusion over 3-hrs every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks.
Andre navn:
  • Yondelis

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Confirmed Objective Response (OR) by Independent External Review (IER)
Tidsramme: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Percentage of participants with confirmed objective response will be based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR is defined as disappearance of all target lesions. PR is those with at least 30 percent decrease in the sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. IER will be done to re-examine all Investigator assessed outcomes.
Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Percentage of Participants With Confirmed Objective Response (OR) by Investigators' Assessment
Tidsramme: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. The CR is defined as disappearance of all target lesions. The PR is those with at least 30 percent decrease in the sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Duration of Response (DR) by Independent Expert Review (IER)
Tidsramme: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Duration of Response is considered as time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as: (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that will be subsequently confirmed plus 1) divided by 30.44. DR will be calculated for the subgroup of participants with a confirmed objective tumor response. IER will be done to re-examine all Investigator assessed outcomes and to provide an independent assessment of response and progression date.
Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Duration of Response (DR) by Investigators' Assessment
Tidsramme: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Duration of Response is considered as time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response is calculated as: (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that will be subsequently confirmed plus 1) divided by 30.44. The DR will be calculated for the subgroup of participants with a confirmed objective tumor response.
Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Progression-Free Survival (PFS) by Independent Expert Review (IER)
Tidsramme: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
PFS is defined as the time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS is calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression will be determined from radiological image (where data meet the criteria for progressive disease [PD]). IER will be done to re-examine all Investigator assessed outcomes and to provide an independent assessment of response and progression date.
Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Progression-Free Survival (PFS) by Investigators' Assessment
Tidsramme: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
PFS is defined as the time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS is calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression will be determined from radiological image (where data meet the criteria for progressive disease [PD]). IER will be done to re-examine all Investigator assessed outcomes and to provide an independent assessment of response and progression date.
Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Number of Participants With Changes in Tumor Volume
Tidsramme: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Three dimensional analysis will be used to measure changes in tumor volume.
Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Number of Participants With Changes in Tumoral Radiological Density
Tidsramme: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Three dimensional analysis will be used to measure changes in tumoral radiological density.
Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Adverse Events
Tidsramme: Baseline up to 30 days after last dose of study drug
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Baseline up to 30 days after last dose of study drug

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Samarbeidspartnere

PharmaMar

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

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

1. juni 2007

Primær fullføring (Faktiske)

1. august 2011

Studiet fullført (Faktiske)

1. august 2011

Datoer for studieregistrering

Først innsendt

20. desember 2007

Først innsendt som oppfylte QC-kriteriene

20. desember 2007

Først lagt ut (Anslag)

24. desember 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

25. februar 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. februar 2014

Sist bekreftet

1. februar 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR014764
  • ET-B-027-06 (Annen identifikator: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)

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