- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02015676
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer
26. februar 2015 opdateret af: Hoffmann-La Roche
'A Study of the Effect of First Line Treatment With Paclitaxel and Myocet in Combination With Herceptin on Overall Tumor Response in Patients With Metastatic or Locally Advanced Breast Cancer and HER2 Overexpression.'
This study will define an optimal chemotherapy dose regimen of Myocet in combination with paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose regimen in patients with metastatic or locally advanced breast cancer and HER2 overexpression.
The anticipated time on study treatment is 3-12 months.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
69
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Madrid, Spanien, 28027
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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
Kvinde
Beskrivelse
Inclusion Criteria:
- women 18-70 years of age;
- metastatic or locally advanced breast cancer;
- HER2 overexpression;
- >= 1 measurable lesion.
Exclusion Criteria:
- prior treatment for advanced breast cancer;
- prior treatment with Herceptin;
- bone or central nervous system metastasis as the only site of disease;
- history of another malignancy (except basal cell skin cancer and cancer in situ of the uterine cervix, and contralateral breast cancer) within 5 years of study.
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: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Trastuzumab, Myocet, Paclitaxel; Phase I
Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression.
Participants also received myocet, 40 mg/ square meter (m^2), IV, every 3 weeks, from Week 1; if no dose limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles.
Participants also received paclitaxel 60 mg/ m^2, IV, once per week, from Week 19; if no DLT was observed in ≥ 2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression.
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Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression
Andre navne:
60 mg/m^2 IV weekly; dose increased to 70 mg/m^2, and subsequently 80 mg/m^2, after 2 treatment cycles with no evidence of DLT until disease progression
40 mg/m^2 IV weekly; dose increased to 50 mg/m^2 IV after 2 treatment cycles with no evidence of DLT for 6 cycles
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Eksperimentel: Trastuzumab, Myocet, Paclitaxel; Phase II
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression.
Participants also received myocet, 50 mg/m^2, IV, every 3 weeks, from Week 1 for 6 cycles.
Participants also received paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
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Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression
Andre navne:
60 mg/m^2 IV weekly; dose increased to 70 mg/m^2, and subsequently 80 mg/m^2, after 2 treatment cycles with no evidence of DLT until disease progression
40 mg/m^2 IV weekly; dose increased to 50 mg/m^2 IV after 2 treatment cycles with no evidence of DLT for 6 cycles
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment
Tidsramme: Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion.
For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks.
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Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Time to Disease Progression - Percentage of Participants With an Event
Tidsramme: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Disease progression was defined as the time from the start of treatment to the date of the first recorded incident of disease progression, or the date of death due any cause.
For measurable disease, disease progression was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of greater than (>)2 square centimeters (cm^2), or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2.
For immeasurable disease, disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Time to Disease Progression
Tidsramme: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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The median time, in months, from the start of treatment to disease progression event.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Time to Treatment Response - Percentage of Participants With an Event
Tidsramme: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Treatment response was defined as the time from the start of treatment to the date of recorded CR or PR of measurable disease.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Time to Treatment Response
Tidsramme: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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The median time, in months, from the start of treatment to treatment response event.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Duration of Response - Percentage of Participants With an Event
Tidsramme: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Duration of response was defined as the time from date CR was first recorded to the date progressive disease (PD) was first noted.
For measurable disease, PD was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of >2 cm^2, or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2.
For immeasurable disease, PD was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Duration of Response
Tidsramme: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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The median time, in months, from enrollment to duration of response event to Week 52.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Time to Therapy Failure - Percentage of Participants With an Event
Tidsramme: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Therapy failure was defined as the date of the start of therapy to the date of withdrawal due to adverse events, progressive disease/insufficient therapeutic response, death, failure to return, or refusal of treatment/lack of cooperation/withdrawal of consent.
Participants were censored at the last dose of treatment if no event was recorded.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Time to Therapy Failure
Tidsramme: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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The median time, in months, from treatment start to therapy failure event.
Participants were censored at the last date of treatment if no event was recorded.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Overall Survival (OS) - Percentage of Participants With an Event
Tidsramme: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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OS was defined as the time from the date of the start of treatment to the date of death or the last date the participant was known to be alive.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Overall Survival
Tidsramme: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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The time, in months, from the start of treatment to OS event.
The mean survival time and it's standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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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. juli 2001
Primær færdiggørelse (Faktiske)
1. september 2009
Studieafslutning (Faktiske)
1. september 2009
Datoer for studieregistrering
Først indsendt
3. december 2013
Først indsendt, der opfyldte QC-kriterier
13. december 2013
Først opslået (Skøn)
19. december 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. marts 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. februar 2015
Sidst verificeret
1. februar 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hudsygdomme
- Neoplasmer
- Neoplasmer efter sted
- Brystsygdomme
- Brystneoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Antineoplastiske midler, immunologiske
- Paclitaxel
- Trastuzumab
Andre undersøgelses-id-numre
- M77035
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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