Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00754325

Purpose

The purpose of this study is to find out what effect the combination of fulvestrant (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant alone.

Condition	Intervention	Phase
Advanced Breast Cancer	Drug: Dasatinib Drug: Fulvestrant	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Ici 182780 Dasatinib

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To estimate progression-free survival (PFS) distribution of subjects with advanced breast cancer treated with either fulvestrant plus dasatinib or single-agent fulvestrant [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall response rate in patients who receive fulvestrant plus dasatinib or single-agent fulvestrant [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
Median PFS in patients in both Arms [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
Time to treatment failure (TTF) [ Time Frame: at 6 months and 1 year ] [ Designated as safety issue: No ]
Changes in bone markers [ Time Frame: at 6 months and 1 year ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: at each clinic visit ] [ Designated as safety issue: Yes ]
Effect on bone pain [ Time Frame: at each clinic visit ] [ Designated as safety issue: No ]
Bone Mineral Density changes [ Time Frame: between baseline and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	September 2008
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm 1 (Dasatinib +Fulvestrant)	Drug: Dasatinib Tablets, Oral, 100 mg, once daily (QD), upto 2 years Other Name: Sprycel Drug: Fulvestrant Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1. In subsequent cycles, 500 mg IM administered on Day 1. IM day 1 and 15 first cycle then IM Day 1 for all other cycles for 2 years Other Name: Faslodex
Active Comparator: Arm 2 (Fulvestrant)	Drug: Fulvestrant Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1. In subsequent cycles, 500 mg IM administered on Day 1. IM day 1 and 15 first cycle then IM Day 1 for all other cycles for 2 years Other Name: Faslodex

Eligibility

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

Criteria

Inclusion Criteria:

Histologically confirmed hormone receptor positive (HR+) [(estrogen receptor (ER+) and/or progesterone receptors(PgR+)] breast cancer according to immunohistochemistry (IHC)
Measureable or evaluable-only disease
human epidermal growth factor receptor 2+ (HER2+) or HER2- breast cancer
Males and females ≥18 years of age
Females are post menopausal or surgically sterile
Recurrent or progressive advanced breast cancer (locally-advanced or metastatic), that has progressed: (a) during or within 12 months after completion of adjuvant Aromatase Inhibitor (AI) treatment OR (b) during AI treatment in advanced setting (metastatic therapy)

Exclusion Criteria:

Pregnant or breast feeding
>1 chemotherapy regimen for advanced disease
Pleural or pericardial effusion
Serious cardiac condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754325

Locations

United States, Arizona
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States, 86336
Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
Tucson, Arizona, United States, 85704
United States, Florida
Florida Cancer Institute - New Hope
Hudson, Florida, United States, 34667
Cancer Centers Of Florida, P.A
Ocoee, Florida, United States, 34761
United States, Indiana
Central Indiana Cancer Centers
Carmel, Indiana, United States, 46032
United States, Kansas
Kansas City Cancer Center, Llc.
Overland Park, Kansas, United States, 66210
United States, Minnesota
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
United States, New York
New York Oncology Hematology, Pc
Troy, New York, United States, 12180
United States, North Carolina
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, United States, 27607
United States, Oregon
Willamette Valley Cancer Center
Eugene, Oregon, United States, 97401
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97213
United States, Texas
Texas Oncology-Austin Central
Austin, Texas, United States, 78731
Texas Oncology, P.A.
Bedford, Texas, United States, 76022
Texas Oncology Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology, P.A.
Dallas, Texas, United States, 75230
Texas Oncology
Dallas, Texas, United States, 75231
Texas Cancer Center
Denton, Texas, United States, 76210
El Paso Cancer Treatment Ctr - West
El Paso, Texas, United States, 79902
Us Oncology Research, Inc.
Houston, Texas, United States, 77060
Texas Oncology
Houston, Texas, United States, 77024
Cancer Care Centers Of South Texas
San Antonio, Texas, United States, 78217
Tyler Cancer Center
Tyler, Texas, United States, 75702
Texas Oncology Cancer Care And Research Center
Waco, Texas, United States, 76712
Texas Oncology, P.A.
Webster, Texas, United States, 77598
United States, Virginia
Virginia Center Specialists, Pc
Fairfax, Virginia, United States, 22031
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Oncology & Hematology Associates Of Southwest Virginia, Inc.
Salem, Virginia, United States, 24153

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

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

Investigator Inquiry form 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

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00754325 History of Changes
Other Study ID Numbers:	CA180-158, USOR 06-030
Study First Received:	August 29, 2008
Last Updated:	February 2, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Aromatase Inhibitors
Dasatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogens
Hormones
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012