Clinical trial NCT00371254: A Study of Dasatinib (BMS-354825) in Patients With Advanced 'Triple-negative' Breast Cancer
Official title: Phase II Study of Dasatinib (BMS-354825) for Advanced 'Triple-negative' Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Metastasis
Keywords: Recurrent, locally-advanced, or 'triple negative' metastatic breast cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-09-04
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced triple-negative breast cancer.


Eligibility criteria: Inclusion Criteria:

* females, 18 or older
* recurrent or progressive locally advanced, or 'triple negative' metastatic breast cancer
* paraffin-embedded tissue block must be available
* measurable disease
* prior chemotherapy with an anthracycline, a taxane, or both (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 CNS metastasis
* Concurrent medical condition which may increase the risk of toxicity
* Unable to take oral medication

Primary outcomes:
measure: Number of Participants With Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline to end of study drug therapy (up to 65 weeks).
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline to end of study drug therapy (up to 65 weeks).
Secondary outcomes:
measure: Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study
timeFrame: Baseline to 16 weeks.
measure: Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study
timeFrame: Baseline to 16 weeks
measure: Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25
timeFrame: Weeks 9, 17, and 25
measure: Mean Number of Weeks of Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline to end of study drug therapy (up to 53.86 weeks)
measure: Mean Plasma Concentration at Week 3
timeFrame: At pre-dose and 1, 3, 6 and 12 hours after each dose administration
measure: Mean Plasma Concentration at Week 7
timeFrame: At pre-dose and 1, 3, 6 and 12 hours after each dose administration
measure: Mean Change in Concentration of Collagen Type IV From Baseline
timeFrame: Baseline, Week 3 and Week 5
measure: Mean Change in Concentration of Vascular Endothelial Growth Factor Receptor-2 (VEGFR2) From Baseline
timeFrame: Baseline, Week 3 and Week 5
measure: Percentage Change in Tumor Biomarkers
timeFrame: Baseline
measure: Profiling of Messenger-ribonucleic Acid (mRNA) Expression: mRNA Signal Intensity
timeFrame: Baseline
measure: Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs) or Adverse Events (AEs)
timeFrame: From start of study drug therapy up to 30 days after the last dose.
measure: Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3 AEs and Discontinuations Due to Drug-related AEs
timeFrame: From start of study drug therapy up to 30 days after the last dose.
measure: Most Frequent Drug-related Adverse Events (AEs)
timeFrame: From start of study drug therapy up to 30 days after the last dose.
measure: Number of Participants With Grade 3 or 4 Abnormalities in Hematology Measurements
timeFrame: Throughout study, from start of study drug therapy up to 30 days after the last dose.
measure: Number of Participants With Abnormalities (Grade 1 or 2) in Prothrombin Time (PT)
timeFrame: Throughout study, from start of study drug therapy up to 30 days after the last dose.
measure: Number of Participants With Abnormalities (Grade 1 or 2) in Partial Thromboplastin Time (PTT)
timeFrame: Throughout study, from start of study drug therapy up to 30 days after the last dose.
measure: Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase
timeFrame: Throughout study, from start of study drug therapy up to 30 days after the last dose.
measure: Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Calcium, Potassium, Magnesium and Sodium
timeFrame: Throughout study, from start of study drug therapy up to 30 days after the last dose.
measure: Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Creatinine, Bicarbonate, Inorganic Phosphorous and Bilirubin (Total).
timeFrame: Throughout study, from start of study drug therapy up to 30 days after the last dose.
measure: Number of Participants With Identified Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline, Weeks 3, 9, 17 and 25, then every 8 weeks until the end of study treatment (up to 17 weeks).
measure: Number of Participants With Abnormal Vital Signs Measurements
timeFrame: At each study visit (Week 3, 5, 7, 9, 13, 17 and 25) and end of treatment (up to 17 weeks)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Ucsf-Comprehensive Cancer Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Boston
country: United States
facility: Dana-Farber Cancer Inst
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Houston
country: United States
facility: University Of Texas Md Anderson Cancer Ctr
state: Texas
city: Paris
country: France
facility: Local Institution
city: Toulouse Cedex 3
country: France
facility: Local Institution
city: Modena
country: Italy
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Lleida
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: