Safety and Efficacy of Exemestane Plus Dasatinib Versus Placebo for Advanced ER+ Breast Cancer

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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 positive (ER+) breast cancer after disease progression (PD) on a non-steroidal aromatase inhibitor (NSAI).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Dasatinib; Estrogens; Exemestane

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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