A Study of Dasatinib (BMS-354825) in Patients With Advanced 'Triple-negative' Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00371254
• Date of registration: 01/09/2006
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: A Study of Dasatinib (BMS-354825) in Patients With Advanced 'Triple-negative' Breast Cancer
• Scientific title: Phase II Study of Dasatinib (BMS-354825) for Advanced 'Triple-negative' Breast Cancer
• Date of first enrolment: December 2006
• Target sample size: 55
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00371254
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Belgium, France, Italy, Spain, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Metastasis

Breast Cancer

Intervention(s)

Drug: Dasatinib

Primary Outcome(s)

Number of Participants With Complete Response (CR) or Partial Response (PR) [Time Frame: Baseline to end of study drug therapy (up to 65 weeks).]

Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Time Frame: Baseline to end of study drug therapy (up to 65 weeks).]

Secondary Outcome(s)

Mean Change in Concentration of Vascular Endothelial Growth Factor Receptor-2 (VEGFR2) From Baseline [Time Frame: Baseline, Week 3 and Week 5]

Most Frequent Drug-related Adverse Events (AEs) [Time Frame: From start of study drug therapy up to 30 days after the last dose.]

Mean Number of Weeks of Complete Response (CR) or Partial Response (PR) [Time Frame: Baseline to end of study drug therapy (up to 53.86 weeks)]

Number of Participants With Abnormalities (Grade 1 or 2) in Prothrombin Time (PT) [Time Frame: Throughout study, from start of study drug therapy up to 30 days after the last dose.]

Mean Plasma Concentration at Week 3 [Time Frame: At pre-dose and 1, 3, 6 and 12 hours after each dose administration]

Mean Change in Concentration of Collagen Type IV From Baseline [Time Frame: Baseline, Week 3 and Week 5]

Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study [Time Frame: Baseline to 16 weeks.]

Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase [Time Frame: Throughout study, from start of study drug therapy up to 30 days after the last dose.]

Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3 AEs and Discontinuations Due to Drug-related AEs [Time Frame: From start of study drug therapy up to 30 days after the last dose.]

Profiling of Messenger-ribonucleic Acid (mRNA) Expression: mRNA Signal Intensity [Time Frame: Baseline]

Percentage Change in Tumor Biomarkers [Time Frame: Baseline]

Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study [Time Frame: Baseline to 16 weeks]

Number of Participants With Abnormal Vital Signs Measurements [Time Frame: At each study visit (Week 3, 5, 7, 9, 13, 17 and 25) and end of treatment (up to 17 weeks)]

Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Calcium, Potassium, Magnesium and Sodium [Time Frame: Throughout study, from start of study drug therapy up to 30 days after the last dose.]

Mean Plasma Concentration at Week 7 [Time Frame: At pre-dose and 1, 3, 6 and 12 hours after each dose administration]

Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs) or Adverse Events (AEs) [Time Frame: From start of study drug therapy up to 30 days after the last dose.]

Number of Participants With Abnormalities (Grade 1 or 2) in Partial Thromboplastin Time (PTT) [Time Frame: Throughout study, from start of study drug therapy up to 30 days after the last dose.]

Number of Participants With Identified Electrocardiogram (ECG) Abnormalities [Time Frame: Baseline, Weeks 3, 9, 17 and 25, then every 8 weeks until the end of study treatment (up to 17 weeks).]

Number of Participants With Grade 3 or 4 Abnormalities in Hematology Measurements [Time Frame: Throughout study, from start of study drug therapy up to 30 days after the last dose.]

Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Creatinine, Bicarbonate, Inorganic Phosphorous and Bilirubin (Total). [Time Frame: Throughout study, from start of study drug therapy up to 30 days after the last dose.]

Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25 [Time Frame: Weeks 9, 17, and 25]

Secondary ID(s)

CA180-059

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/03/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00371254