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A Randomized, Double-Blind, Multi-Center Phase II Trial of Exemestane (Aromasin®) Plus Dasatinib Versus Exemestane Plus Placebo in Advanced Estrogen Receptor-Positive Breast Cancer After Disease Progression on a Non-Steroidal Aromatase Inhibitor (NSAI)


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

A Randomized, Double-Blind, Multi-Center Phase II Trial of Exemestane (Aromasin®) Plus Dasatinib Versus Exemestane Plus Placebo in Advanced Estrogen Receptor-Positive Breast Cancer After Disease Progression on a Non-Steroidal Aromatase Inhibitor (NSAI)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo

Outcome Description:

PFS= The time (weeks) from date of randomization to date of progressive disease(PD). PFS for each randomization arm was estimated using the Kaplan-Meier product-limit method. A point estimate and a 95% confidence interval (CI) for the median PFS was computed for each randomization arm using the Brookmeyer & Crowley method. PD=Increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).

Outcome Time Frame:

Prior to study therapy, at 8 week intervals until progression occurs (maximum participant PFS of 71 weeks)

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-261

NCT ID:

NCT00767520

Start Date:

February 2009

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Advanced Estrogen Receptor Positive Breast Cancer
  • Breast Neoplasms

Name

Location

The West Clinic Memphis, Tennessee  38120
Compassionate Cancer Care Medical Group, Inc Fountain Valley, California  92708
Compassionate Cancer Care Medical Group Inc Fountain Valley, California  92708
Pennsylvania Oncology/Hematology Associates Philadelphia, Pennsylvania  19106