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

26 lutego 2015 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

69

Faza

  • Faza 2
  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 70 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: trastuzumab
Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression
Inne nazwy:
  • Herceptyna
Lek: 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
Lek: 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
Eksperymentalny: 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.
Lek: trastuzumab
Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression
Inne nazwy:
  • Herceptyna
Lek: 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
Lek: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Time to Disease Progression - Percentage of Participants With an Event
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hoffmann-La Roche

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lipca 2001

Zakończenie podstawowe (Rzeczywisty)

1 września 2009

Ukończenie studiów (Rzeczywisty)

1 września 2009

Daty rejestracji na studia

Pierwszy przesłany

3 grudnia 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 grudnia 2013

Pierwszy wysłany (Oszacować)

19 grudnia 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

12 marca 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

26 lutego 2015

Ostatnia weryfikacja

1 lutego 2015

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • M77035

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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