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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 aprile 2011 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

92

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Droga: Dasatinib
Tablets, Oral, 70 mg, twice daily, as long as the participant benefits (average <6 months)
Altri nomi:
  • BMS-354825
  • Sprycel
Droga: Dasatinib 100 mg
Tablets, Oral, 100mg, twice daily, as long as the participant benefits (average <6 months)
Altri nomi:
  • BMS-354825
  • Sprycel

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Objective Response
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Response-evaluable Participants With Disease Control (DCR)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bristol-Myers Squibb

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2006

Completamento primario (Effettivo)

1 marzo 2009

Completamento dello studio (Effettivo)

1 maggio 2009

Date di iscrizione allo studio

Primo inviato

1 settembre 2006

Primo inviato che soddisfa i criteri di controllo qualità

1 settembre 2006

Primo Inserito (Stima)

4 settembre 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 aprile 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 aprile 2011

Ultimo verificato

1 aprile 2011

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CA180-088

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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