Status:
COMPLETED
Safety and Efficacy of Exemestane Plus Dasatinib Versus Placebo for Advanced ER+ Breast Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether exemestane plus dasatinib will be well-tolerated and will increase progression-free survival (PFS) in the treatment of advanced estrogen-receptor posi...
Eligibility Criteria
Inclusion
- Histologically-documented invasive estrogen receptor positive breast cancer , with tumor tissue from prior surgery available for analysis
- Prior therapy with a non-steroidal aromatase inhibitor
- Recurrent or progressive advanced breast cancer (locally-advanced or metastatic)
- Documented breast cancer with tumor ≤ 28 days prior to study entry
- Women who are NOT of childbearing potential
- Must be able to take oral medication
- Performance Status 0 or 1
Exclusion
- Pleural or pericardial effusion or ascites (of any etiology; Grade ≥ 1) within 6 months prior to study entry
- Any chemotherapy, immunotherapy \< 6 months before study entry. Any targeted therapy (eg. lapatinib) \< 6 months before study entry, unless given in combination with an NSAI
- Any antitumor therapy, including radiotherapy or hormonal therapy, within 15 days prior to study entry
- Prior exposure to exemestane, any Src-family kinase inhibitor including dasatinib, to agents intended to control osteolytic disease other than bisphosphonates, or to any investigational agent for breast cancer
- Concurrent or previous malignant disease requiring chemotherapy or radiation treatment within the prior 3 years
- Significant bleeding disorder, or ongoing or recent clinically-significant gastrointestinal bleeding
- Any serious cardiac condition, including congestive heart failure or myocardial infarction within 6 months, uncontrolled angina, or Class III or IV heart disease as defined by the New York Heart Association, baseline ejection fraction ≤ 40%, diagnosed congenital long QT syndrome, clinically-significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes), QTc interval \> 450 msec at baseline (Fridericia correction)
- Hematologic abnormality Grade ≥ 2
- Hypocalcemia of Grade ≥ 1
- Any Chemistry abnormality of Grade ≥ 2 \[except Grade 2 indirect bilirubin permitted if diagnosed Gilbert's disease\]
- Pregnant Women and Women of Childbearing Potential (WOCBP)
- Extremely lactose intolerant, in the judgment of treating physician (100 mg dasatinib contains 135 mg lactose, posing a problem only if intolerance is severe)
- Receiving any of the following concomitant medications: Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Subjects must discontinue drug use at least 7 days prior to starting dasatinib)
- Potent inhibitors of CYP3A4 isoenzyme
- Prisoners or subjects who are involuntarily incarcerated; or subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00767520
Start Date
February 1 2009
End Date
December 1 2012
Last Update
February 28 2013
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Compassionate Cancer Care Medical Group, Inc
Fountain Valley, California, United States, 92708
2
Compassionate Cancer Care Medical Group Inc
Riverside, California, United States, 92501
3
Pennsylvania Oncology/Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
4
The West Clinic
Memphis, Tennessee, United States, 38120