Clinical trial NCT00371345: Study of Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast Cancer
Official title: Phase II Study of Dasatinib (BMS-354825) for Advanced Estrogen/Progesterone Receptor-Positive or Her2/Neu-Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Metastasis
Keywords: Recurrent, locally-advanced, or metastatic breast cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-09-04
Enrollment: 92
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 ER+/PR+ or Her2/neu+ breast cancer


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Objective Response
timeFrame: From day of first treatment through Week 25 or at time of discontinuation from study treatment.
measure: Percentage of Participants With Objective Response
timeFrame: From day of first treatment through Week 25 or at time of discontinuation from study treatment
measure: Best Overall Response
timeFrame: From day of first treatment through Week 25 or at time of discontinuation from study treatment
Secondary outcomes:
measure: Number of Response-evaluable Participants With Disease Control (DCR)
timeFrame: From day of first treatment through Week 25 or at time of discontinuation from study treatment.
measure: Percentage of Response-evaluable Participants With Disease Control (DCR)
timeFrame: From day of first treatment through Week 25 or at time of discontinuation from study treatment.
measure: Number of Participants Who Progressed
timeFrame: From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)
measure: Median Progression Free Survival (PFS)
timeFrame: From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)
measure: Percentage of Participants With Progression-free Survival (PFS) at Weeks 9, 17, and 25
timeFrame: At Weeks 9, 17, and 25
measure: Duration Of Objective Response
timeFrame: the time (in weeks) between the first date that criteria for PR were met and the first date that PD or cPD was observed
measure: Number of Participants With Death, Adverse Events (AEs), and AEs Leading to Discontinuation
timeFrame: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
measure: Number of Participants With On-study CTCAE Version 3.0 Grade 3-4 Laboratory Abnormalities
timeFrame: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
measure: Number of Participants With Serious AEs (SAEs), Drug-related AEs, Drug-related SAEs, and Drug-Related Grade 3 AEs
timeFrame: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
measure: Number Of Participants With Notable Drug-related AEs
timeFrame: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
measure: Pharmacokinetics (PK): Plasma Concentration of Dasatinib at Week 3
timeFrame: 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).
measure: PK: Plasma Concentration of Dasatinib at Week 7 or Week 9
timeFrame: 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).
measure: Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 3 in Participants With and Without DCR
timeFrame: At Baseline and Week 3 of treatment (Day 15 ±4 days)
measure: Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 5 in Participants With and Without DCR
timeFrame: Week 5
measure: Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 3 in Participants With and Without DCR
timeFrame: At Baseline and Week 3 of treatment (Day 15 ±4 days)
measure: Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 5 in Participants With and Without DCR
timeFrame: At Baseline and Week 5 of treatment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Ucsf-Comprehensive Cancer Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
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: Chapel Hill
country: United States
facility: University Of North Carolina At Chapel Hill
state: North Carolina
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: University Of Texas Md Anderson Cancer Ctr
state: Texas
city: Haedo
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Dijon Cedex
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Saint Herblain Cedex
country: France
facility: Local Institution
city: Toulouse Cedex 3
country: France
facility: Local Institution
city: Modena
country: Italy
facility: Local Institution
city: Arequipa
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Lleida
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: