Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer

26. února 2015 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

69

Fáze

  • Fáze 2
  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 70 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: trastuzumab
Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression
Ostatní jména:
  • Herceptin
Lék: paclitaxel
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
Lék: Myocet
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
Experimentální: 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.
Lék: trastuzumab
Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression
Ostatní jména:
  • Herceptin
Lék: paclitaxel
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
Lék: Myocet
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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment
Časové okno: Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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.
Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time to Disease Progression - Percentage of Participants With an Event
Časové okno: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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.
BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Time to Disease Progression
Časové okno: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
The median time, in months, from the start of treatment to disease progression event.
BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Time to Treatment Response - Percentage of Participants With an Event
Časové okno: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Treatment response was defined as the time from the start of treatment to the date of recorded CR or PR of measurable disease.
BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Time to Treatment Response
Časové okno: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
The median time, in months, from the start of treatment to treatment response event.
BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Duration of Response - Percentage of Participants With an Event
Časové okno: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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.
BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Duration of Response
Časové okno: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
The median time, in months, from enrollment to duration of response event to Week 52.
BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Time to Therapy Failure - Percentage of Participants With an Event
Časové okno: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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.
BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Time to Therapy Failure
Časové okno: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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.
BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Overall Survival (OS) - Percentage of Participants With an Event
Časové okno: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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.
BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Overall Survival
Časové okno: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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.
BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hoffmann-La Roche

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. července 2001

Primární dokončení (Aktuální)

1. září 2009

Dokončení studie (Aktuální)

1. září 2009

Termíny zápisu do studia

První předloženo

3. prosince 2013

První předloženo, které splnilo kritéria kontroly kvality

13. prosince 2013

První zveřejněno (Odhad)

19. prosince 2013

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

12. března 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. února 2015

Naposledy ověřeno

1. února 2015

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • M77035

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Rakovina prsu

Klinické studie na trastuzumab

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Qatar

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit