Safety and Efficacy of Exemestane Plus Dasatinib Versus Placebo for Advanced ER+ Breast Cancer - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00767520

Purpose

The purpose of this study is to determine whether exemestane plus dasatinib will be well-tolerated and will increase progression-free survival in the treatment of advanced ER+ breast cancer

Condition	Intervention	Phase
Breast Cancer	Drug: Exemestane + Dasatinib Drug: Exemestane + Placebo	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Dasatinib Exemestane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Multi-Center Phase II Trial of Exemestane (AromasinÂ®) Plus Dasatinib Versus Exemestane Plus Placebo in Advanced ER+ Breast Cancer After Disease Progression on a Non-Steroidal Aromatase Inhibitor

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Progression Free Survival distribution for exemestane plus dasatinib vs exemestane plus placebo [ Time Frame: at 8 week intervals until progression occurs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Benefit Rate (CBR) and Freedom-From-Progression (FFP-6) in each treatment arm [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
In response - evaluable subjects - An estimate of Objective Response Rate (ORR), Time to Response and Response Duration in each treatment arm [ Time Frame: Those with at least one baseline tumor assessment and one at 8 weeks on treatment ] [ Designated as safety issue: No ]
To assess safety and tolerability in each treatment arm [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
In subjects with bone metastasis, to evaluate changes in subject-reported pain intensity and markers of bone lysis in each treatment arm [ Time Frame: every 3 weeks up to week 9 and every 8 weeks thereafter ] [ Designated as safety issue: No ]

Estimated Enrollment:	156
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: Exemestane + Dasatinib Tablets, Oral, Exemestane 25 mg + Dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
B: Placebo Comparator	Drug: Exemestane + Placebo Tablets, Oral, Exemestane 25 mg + Placebo 100 mg, once daily, until disease progression or unacceptable toxicity

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Invasive estrogen receptor positive breast cancer, locally-advanced or metastatic, with tumor tissue from prior surgery available for analysis
Prior therapy with a non-steroidal aromatase inhibitor in the adjuvant or advanced setting
Ability to take oral meds

Exclusion Criteria:

Pleural or pericardial effusion or ascites
Any chemotherapy, immunotherapy or antibody therapy for advanced breast cancer
Any antitumor therapy, including radiotherapy or hormonal therapy, within 15 days prior to study entry
Prior exposure to exemestane, any Src inhibitor including dasatinib

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767520

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 35 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA180-261
Study First Received:	October 6, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00767520
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Advanced Estrogen Receptor Positive Breast Cancer

Study placed in the following topic categories:

Skin Diseases
Dasatinib
Disease Progression

Breast Neoplasms
Exemestane
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Aromatase Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009