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

NCT ID: NCT00767520

Last Updated: 2013-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-12-31

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

Conditions

Breast Cancer

Keywords

Advanced Estrogen Receptor Positive Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

Group Type: ACTIVE_COMPARATOR

Exemestane + Dasatinib

Intervention Type: DRUG

Tablets, Oral, Exemestane 25 mg + Dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity

B

Group Type: PLACEBO_COMPARATOR

Exemestane + Placebo

Intervention Type: DRUG

Tablets, Oral, Exemestane 25 mg + Placebo 100 mg, once daily, until disease progression or unacceptable toxicity

Interventions

Exemestane + Dasatinib

Tablets, Oral, Exemestane 25 mg + Dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity

Intervention Type: DRUG

Exemestane + Placebo

Tablets, Oral, Exemestane 25 mg + Placebo 100 mg, once daily, until disease progression or unacceptable toxicity

Intervention Type: DRUG

Other Intervention Names

Sprycel; BMS-354825

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Compassionate Cancer Care Medical Group, Inc

Fountain Valley, California, United States

Compassionate Cancer Care Medical Group Inc

Riverside, California, United States

Pennsylvania Oncology/Hematology Associates

Philadelphia, Pennsylvania, United States

The West Clinic

Memphis, Tennessee, United States

Local Institution

Hradec Králové, , Czechia

Local Institution

Prague, , Czechia

Local Institution

Lille, , France

Local Institution

Paris, , France

Local Institution

Saint-Cloud, , France

Local Institution

Dublin, Dublin, Ireland

Local Institution

Gdansk, , Poland

Local Institution

Gdansk, , Poland

Local Institution

Lodz, , Poland

Local Institution

Opole, , Poland

Local Institution

Madrid, , Spain

Local Institution

Madrid, , Spain

Local Institution

Torrevieja, , Spain

Local Institution

Västerås, , Sweden

Local Institution

Chelmsford, Essex, United Kingdom

Local Institution

London, Greater London, United Kingdom

Local Institution

Coventry, Warwickshire, United Kingdom

Countries

Italy; Norway; South Korea; Taiwan; United States; Czechia; France; Ireland; Poland; Spain; Sweden; United Kingdom

Related Links

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

CA180-261

Identifier Type: -

Identifier Source: org_study_id