- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02015676
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer
26. Februar 2015 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
69
Phase
- Phase 2
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Madrid, Spanien, 28027
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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
Andere Namen:
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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Experimental: 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
Andere Namen:
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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Time to Disease Progression - Percentage of Participants With an Event
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Juli 2001
Primärer Abschluss (Tatsächlich)
1. September 2009
Studienabschluss (Tatsächlich)
1. September 2009
Studienanmeldedaten
Zuerst eingereicht
3. Dezember 2013
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. Dezember 2013
Zuerst gepostet (Schätzen)
19. Dezember 2013
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
12. März 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. Februar 2015
Zuletzt verifiziert
1. Februar 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Hautkrankheiten
- Neubildungen
- Neubildungen nach Standort
- Brusterkrankungen
- Neoplasien der Brust
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antineoplastische Mittel
- Tubulin-Modulatoren
- Antimitotische Mittel
- Mitose-Modulatoren
- Antineoplastische Mittel, Phytogen
- Antineoplastische Mittel, immunologische
- Paclitaxel
- Trastuzumab
Andere Studien-ID-Nummern
- M77035
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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