- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02015676
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer
26. februar 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
69
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Madrid, Spania, 28027
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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 til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
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
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 |
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Eksperimentell: 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 navn:
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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Eksperimentell: 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 navn:
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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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. juli 2001
Primær fullføring (Faktiske)
1. september 2009
Studiet fullført (Faktiske)
1. september 2009
Datoer for studieregistrering
Først innsendt
3. desember 2013
Først innsendt som oppfylte QC-kriteriene
13. desember 2013
Først lagt ut (Anslag)
19. desember 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
12. mars 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. februar 2015
Sist bekreftet
1. februar 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Hudsykdommer
- Neoplasmer
- Neoplasmer etter nettsted
- Bryst sykdommer
- Brystneoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Antineoplastiske midler, fytogene
- Antineoplastiske midler, immunologiske
- Paklitaksel
- Trastuzumab
Andre studie-ID-numre
- M77035
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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