Phase 2 N=70 Treatment

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

Breast Cancer · Metastasis

Bottom Line

View on ClinicalTrials.gov: NCT00371345 ↗

Enrolled (actual)

Serious AEs

28.6%

Results posted

Nov 2010

Primary outcome: Primary: Number of Participants With Objective Response — 0; 1; 1; 1 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Dasatinib (Drug); Dasatinib 100 mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Bristol-Myers Squibb
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Objective Response	0; 1; 1; 1	—
PRIMARY Percentage of Participants With Objective Response	0; 11.11; 3.23; 7.14; 4.35	—
PRIMARY Best Overall Response	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Response-evaluable Participants With Disease Control (DCR)	0; 0; 0; 0; 0; 0	—
SECONDARY Percentage of Response-evaluable Participants With Disease Control (DCR)	6.67; 11.11; 16.13; 14.29	—
SECONDARY Number of Participants Who Progressed	22; 39; 61	—
SECONDARY Median Progression Free Survival (PFS)	8.1; 8.1	—
SECONDARY Percentage of Participants With Progression-free Survival (PFS) at Weeks 9, 17, and 25	21; 50; 32; 33; 7; 25	—
SECONDARY Duration Of Objective Response	31.14; 18.14; 8.29	—
SECONDARY Number of Participants With Death, Adverse Events (AEs), and AEs Leading to Discontinuation	6; 6; 23; 47; 5; 11	—
SECONDARY Number of Participants With On-study CTCAE Version 3.0 Grade 3-4 Laboratory Abnormalities	1; 1; 0; 1; 0; 1	—
SECONDARY Number of Participants With Serious AEs (SAEs), Drug-related AEs, Drug-related SAEs, and Drug-Related Grade 3 AEs	22; 44; 9; 11; 6; 7	—
SECONDARY Number Of Participants With Notable Drug-related AEs	10; 22; 8; 16; 2; 11	—
SECONDARY Pharmacokinetics (PK): Plasma Concentration of Dasatinib at Week 3	10.82; 6.96; 107.09; 77.21; 58.01; 30.21	—
SECONDARY PK: Plasma Concentration of Dasatinib at Week 7 or Week 9	9.49; 6.62; 6.06; 131.09; 49.28; 4.75	—
SECONDARY Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 3 in Participants With and Without DCR	32.07; 35.92; 22.01; 40.74; 31.35; 36.67	—
SECONDARY Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 5 in Participants With and Without DCR	45.37; 28.45; 17.13; 64.51; 41.33; 34.97	—
SECONDARY Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 3 in Participants With and Without DCR	21.88; 23.61; 14.77; -5.03; 21.37; 18.57	—
SECONDARY Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 5 in Participants With and Without DCR	27.23; 26.36; 16.46; 37.25; 25.77; 28.47	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00371345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.