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Study of Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast Cancer

21. April 2011 aktualisiert von: Bristol-Myers Squibb

Phase II Study of Dasatinib (BMS-354825) for Advanced Estrogen/Progesterone Receptor-Positive or Her2/Neu-Positive Breast Cancer

This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

92

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Argentinien
      • Buenos Aires, Argentinien, 1019
        • Local Institution
      • Buenos Aires, Argentinien, 1185
        • Local Institution
    • Buenos Aires
      • Haedo, Buenos Aires, Argentinien, 1684
        • Local Institution
  • Belgien
      • Bruxelles, Belgien, 1200
        • Local Institution
      • Bruxelles, Belgien, 1000
        • Local Institution
  • Frankreich
      • Dijon Cedex, Frankreich, 21079
        • Local Institution
      • Paris, Frankreich, 75231
        • Local Institution
      • Saint Herblain Cedex, Frankreich, 44805
        • Local Institution
      • Toulouse Cedex 3, Frankreich, 31052
        • Local Institution
  • Italien
      • Modena, Italien, 41100
        • Local Institution
  • Peru
      • Arequipa, Peru
        • Local Institution
      • Lima, Peru, LIMA 11
        • Local Institution
      • Lima, Peru, 34
        • Local Institution
  • Spanien
      • Barcelona, Spanien, 08035
        • Local Institution
      • Lleida, Spanien, 25198
        • Local Institution
      • Madrid, Spanien, 28041
        • Local Institution
  • Vereinigte Staaten
    • California
      • San Francisco, California, Vereinigte Staaten, 94143
        • Ucsf-Comprehensive Cancer Center
    • Florida
      • Jacksonville, Florida, Vereinigte Staaten, 32224
        • Mayo Clinic Florida
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02115
        • Dana-Farber Cancer Inst
    • New York
      • Bronx, New York, Vereinigte Staaten, 10461
        • Montefiore Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Vereinigte Staaten, 275997305
        • University of North Carolina at Chapel Hill
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19111
        • Fox Chase Cancer Center
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77030
        • University Of Texas Md Anderson Cancer Ctr

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 und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

Inclusion Criteria:

  • females, 18 or older
  • recurrent, locally advanced, or metastatic breast cancer with expression of ER/PR receptor and/or overexpression of Her2/neu
  • paraffin-embedded tissue block must be available
  • measurable disease
  • prior chemotherapy with an anthracycline and/or a taxane (neoadjuvant, adjuvant, or metastatic setting)
  • 0, 1 or 2 chemotherapies in the metastatic setting
  • adequate organ function

Exclusion Criteria:

  • Metastatic disease confined to bone only
  • Symptomatic central nervous system (CNS) metastasis
  • Concurrent medical condition which may increase the risk of toxicity
  • Unable to take oral medication

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
Experimental: Dasatinib
Participants with either a Human epidermal growth factor (Her2/neu)-amplified tumor type or ER and/or PgR positive tumor types received oral dasatinib twice daily (BID).
Arzneimittel: Dasatinib
Tablets, Oral, 70 mg, twice daily, as long as the participant benefits (average <6 months)
Andere Namen:
  • BMS-354825
  • Sprycel
Arzneimittel: Dasatinib 100 mg
Tablets, Oral, 100mg, twice daily, as long as the participant benefits (average <6 months)
Andere Namen:
  • BMS-354825
  • Sprycel

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Objective Response
Zeitfenster: From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR.
From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Percentage of Participants With Objective Response
Zeitfenster: From day of first treatment through Week 25 or at time of discontinuation from study treatment
Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.
From day of first treatment through Week 25 or at time of discontinuation from study treatment
Best Overall Response
Zeitfenster: From day of first treatment through Week 25 or at time of discontinuation from study treatment
Response assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions; Partial Response (PR)=≥30% decrease in sum of longest diameter (LD) of target lesions; SD=small changes not meeting above criteria; Progressive Disease (PD)=appearance of new lesion(s), ≥ 20% increase in the sum of the LD of target lesions, or progression of existing non-target lesions; Clinical Progression (cPD)=deterioration related to disease requiring treatment without radiographic PD.
From day of first treatment through Week 25 or at time of discontinuation from study treatment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Response-evaluable Participants With Disease Control (DCR)
Zeitfenster: From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Disease control was defined in response-evaluable participants as having a best response of CR or PR (or uPR), or SD at/after 16 Weeks.
From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Percentage of Response-evaluable Participants With Disease Control (DCR)
Zeitfenster: From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Disease control was defined in response-evaluable participants as having a best response of objective response (CR or PR) or SD at/after 16 Weeks.
From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Number of Participants Who Progressed
Zeitfenster: From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)
PFS was defined as time from first dosing date until the first date that Progressive Disease (PD) was observed.
From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)
Median Progression Free Survival (PFS)
Zeitfenster: From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)
PFS was defined as time from first dosing date until the first date that PD was observed. The distribution of PFS was estimated using the Kaplan-Meier product limit method. A two-sided 95% confidence interval (Brookmeyer and Crowley method) for the median PFS was computed.
From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)
Percentage of Participants With Progression-free Survival (PFS) at Weeks 9, 17, and 25
Zeitfenster: At Weeks 9, 17, and 25
PFS was defined as time from first dosing date until the first date that progressive disease (PD) was observed.
At Weeks 9, 17, and 25
Duration Of Objective Response
Zeitfenster: the time (in weeks) between the first date that criteria for PR were met and the first date that PD or cPD was observed
Duration of objective response was defined as the time (in weeks) between the first date that criteria for CR or PR were met and the first date that progressive disease (PD) or clinical progressive disease (cPD) was observed. Date of death was used as PD date for participants who died before reporting PD. Participants who neither progressed nor died were censored at the date of their last tumor assessment.
the time (in weeks) between the first date that criteria for PR were met and the first date that PD or cPD was observed
Number of Participants With Death, Adverse Events (AEs), and AEs Leading to Discontinuation
Zeitfenster: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Number of Participants With On-study CTCAE Version 3.0 Grade 3-4 Laboratory Abnormalities
Zeitfenster: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Normal ranges for laboratory abnormalities: granulocytes=1.5x10^3-8x10^3 mm^3 (range may have varied by institution); hemoglobin=12-16 g/dL; platelets=150-440x10^9c/L; partial thromboplastin time=27-37.1 seconds; alkaline phosphatase=38-126 U/L; alanine aminotransferase=15-48 U/L; aspartate aminotransferase=14-38 U/L; creatine=0.7-1.1 mg/dL; hypokalemia (potassium [K])=3.5-5mEq/L; hyponatremia (sodium [Na])=135-145 mEq/L; phosphorous=2.4-4.5 mg/dL; bilirubin=0-1.2. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening/disabling, Gr 5=Death.
Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Number of Participants With Serious AEs (SAEs), Drug-related AEs, Drug-related SAEs, and Drug-Related Grade 3 AEs
Zeitfenster: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to CTCAE Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Number Of Participants With Notable Drug-related AEs
Zeitfenster: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Notable drug-related AEs for dasatinib include gastrointestinal symptoms (diarrhea, nausea, vomiting and abdominal pain), fatigue, lethargy, headache, rash, fever, pleural effusion, and dyspnea.
Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Pharmacokinetics (PK): Plasma Concentration of Dasatinib at Week 3
Zeitfenster: PK assessment was performed at Week 3 visit (Day 15 ±4 days). Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).
Blood samples (3 mL) were used for measurement of dasatinib plasma concentration and metabolites.
PK assessment was performed at Week 3 visit (Day 15 ±4 days). Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).
PK: Plasma Concentration of Dasatinib at Week 7 or Week 9
Zeitfenster: PK assessment was performed at Week 7 or 9 visit. Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).
Blood samples (3 mL) were used for measurement of dasatinib plasma concentration and metabolites.
PK assessment was performed at Week 7 or 9 visit. Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).
Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 3 in Participants With and Without DCR
Zeitfenster: At Baseline and Week 3 of treatment (Day 15 ±4 days)
Collagen Type IV is a circulating marker related to the modulation of the vascular endothelial growth factor (VEGF)-pathway. An assay of Collagen Type IV in plasma was performed by ELISA.
At Baseline and Week 3 of treatment (Day 15 ±4 days)
Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 5 in Participants With and Without DCR
Zeitfenster: Week 5
Collagen Type IV is a circulating marker related to the modulation of the vascular endothelial growth factor (VEGF)-pathway. An assay of Collagen Type IV in plasma was performed by ELISA.
Week 5
Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 3 in Participants With and Without DCR
Zeitfenster: At Baseline and Week 3 of treatment (Day 15 ±4 days)
VEGF-stimulated disruption of the cadherin-catenin complex leads to tumor cell invasion and metastasis. VEGFR2 plasma levels were assayed by ELISA as a marker of VEGF pathway modulation.
At Baseline and Week 3 of treatment (Day 15 ±4 days)
Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 5 in Participants With and Without DCR
Zeitfenster: At Baseline and Week 5 of treatment
VEGF-stimulated disruption of the cadherin-catenin complex leads to tumor cell invasion and metastasis. VEGFR2 plasma levels were assayed by ELISA as a marker of VEGF pathway modulation.
At Baseline and Week 5 of treatment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Bristol-Myers Squibb

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. Dezember 2006

Primärer Abschluss (Tatsächlich)

1. März 2009

Studienabschluss (Tatsächlich)

1. Mai 2009

Studienanmeldedaten

Zuerst eingereicht

1. September 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. September 2006

Zuerst gepostet (Schätzen)

4. September 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

26. April 2011

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. April 2011

Zuletzt verifiziert

1. April 2011

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CA180-088

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