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
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
2 other identifiers
interventional
100
1 country
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2008
Longer than P75 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedFirst Posted
Study publicly available on registry
September 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
May 25, 2016
CompletedMay 26, 2016
May 1, 2016
3.2 years
August 29, 2008
May 16, 2016
May 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Disease Progression (PD) or Death
This endpoint evaluated the progression free survival (PFS) of participants amongst the total evaluable population. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Participants with no recorded post-baseline tumor assessment had PFS censored at the day of randomization. Participants lost to follow-up were censored at the last date of contact. Participants that had not progressed or died had PFS censored at the date of last follow-up.
Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
Secondary Outcomes (6)
Median Time of Progression-free Survival (PFS)
Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
Percentage of Participants With Progression Free Survival (PFS) at 6 Months
at 6 months
Percentage of Participants With Clinical Benefit for At Least 6 Months
Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
Number of Participants With Complete Response (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD)
Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
Number of Participants With Best Overall Response
Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
- +1 more secondary outcomes
Study Arms (2)
Arm 1 (Dasatinib +Fulvestrant)
ACTIVE COMPARATORArm 2 (Fulvestrant)
ACTIVE COMPARATORInterventions
Tablets, Oral, 100 mg, once daily (QD), upto 2 years
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Pregnant or breast feeding
- \>1 chemotherapy regimen for advanced disease
- Pleural or pericardial effusion
- Serious cardiac condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, 86336-4937, United States
Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
Tucson, Arizona, 85704, United States
Florida Cancer Institute - New Hope
Hudson, Florida, 34667-6594, United States
Cancer Centers Of Florida, P.A
Ocoee, Florida, 34761, United States
Central Indiana Cancer Centers
Carmel, Indiana, 46032, United States
Kansas City Cancer Center, Llc.
Overland Park, Kansas, 66210, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
New York Oncology Hematology, Pc
Troy, New York, 12180, United States
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, 27607, United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97213, United States
Texas Oncology-Central Austin Cancer Center
Austin, Texas, 78731, United States
Texas Oncology, P.A.
Bedford, Texas, 76022, United States
Texas Oncology, P.A.
Dallas, Texas, 75230-2510, United States
Texas Oncology
Dallas, Texas, 75231, United States
Texas Oncology Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Cancer Center
Denton, Texas, 76210, United States
El Paso Cancer Treatment Ctr - West
El Paso, Texas, 79902, United States
Us Oncology Research, Inc.
Houston, Texas, 77060, United States
Quest Diagnostic Clinical Laboratories Inc
Houston, Texas, 77072, United States
Cancer Care Centers Of South Texas
San Antonio, Texas, 78217, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Texas Oncology Cancer Care And Research Center
Waco, Texas, 76712, United States
Texas Oncology, P.A.
Webster, Texas, 77598-4420, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Oncology & Hematology Associates Of Southwest Virginia, Inc.
Salem, Virginia, 24153, United States
Virginia Center Specialists, Pc
Woodbridge, Virginia, 22191, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2008
First Posted
September 17, 2008
Study Start
September 1, 2008
Primary Completion
November 1, 2011
Study Completion
January 1, 2014
Last Updated
May 26, 2016
Results First Posted
May 25, 2016
Record last verified: 2016-05