- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00754325
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
May 25, 2016 updated by: Bristol-Myers Squibb
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Sedona, Arizona, United States, 86336-4937
- Northern Arizona Hematology & Oncology Associates
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Tucson, Arizona, United States, 85704
- Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
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Florida
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Hudson, Florida, United States, 34667-6594
- Florida Cancer Institute - New Hope
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Ocoee, Florida, United States, 34761
- Cancer Centers Of Florida, P.A
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Indiana
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Carmel, Indiana, United States, 46032
- Central Indiana Cancer Centers
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Kansas
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Overland Park, Kansas, United States, 66210
- Kansas City Cancer Center, Llc.
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Minnesota Oncology Hematology, P.A.
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Missouri
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Columbia, Missouri, United States, 65201
- Missouri Cancer Associates
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New York
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Troy, New York, United States, 12180
- New York Oncology Hematology, PC
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North Carolina
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Raleigh, North Carolina, United States, 27607
- Raleigh Hematology Oncology Associates
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Oregon
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Eugene, Oregon, United States, 97401
- Willamette Valley Cancer Center
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Portland, Oregon, United States, 97213
- Northwest Cancer Specialists, P.C.
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Texas
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Austin, Texas, United States, 78731
- Texas Oncology-Central Austin Cancer Center
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Bedford, Texas, United States, 76022
- Texas Oncology, P.A.
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Dallas, Texas, United States, 75231
- Texas Oncology
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Dallas, Texas, United States, 75246
- Texas Oncology Sammons Cancer Center
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Dallas, Texas, United States, 75230-2510
- Texas Oncology, P.A.
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Denton, Texas, United States, 76210
- Texas Cancer Center
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El Paso, Texas, United States, 79902
- El Paso Cancer Treatment Ctr - West
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Houston, Texas, United States, 77060
- US Oncology Research, Inc.
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Houston, Texas, United States, 77072
- Quest Diagnostic Clinical Laboratories Inc
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San Antonio, Texas, United States, 78217
- Cancer Care Centers of South Texas
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Tyler, Texas, United States, 75702
- Tyler Cancer Center
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Waco, Texas, United States, 76712
- Texas Oncology Cancer Care and Research Center
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Webster, Texas, United States, 77598-4420
- Texas Oncology, P.A.
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Virginia
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Norfolk, Virginia, United States, 23502
- Virginia Oncology Associates
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Salem, Virginia, United States, 24153
- Oncology & Hematology Associates Of Southwest Virginia, Inc.
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Woodbridge, Virginia, United States, 22191
- Virginia Center Specialists, Pc
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
For more information regarding Bristol-Myers Squibb (BMS) clinical trial participation, please visit www.BMSStudyConnect.com.
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 1 (Dasatinib +Fulvestrant)
|
Tablets, Oral, 100 mg, once daily (QD), upto 2 years
Other Names:
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 Names:
|
Active Comparator: Arm 2 (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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Disease Progression (PD) or Death
Time Frame: Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
|
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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Time of Progression-free Survival (PFS)
Time Frame: Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
|
Progression free survival (PFS) was defined as the time in months 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.
Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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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
Time Frame: at 6 months
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PFS rate was defined as the percentage of participants experiencing no disease progression or death from any cause at 6 months after randomization.
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.
Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Kaplan Meier assessments were used to estimate the percentages.
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at 6 months
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Percentage of Participants With Clinical Benefit for At Least 6 Months
Time Frame: Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
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Clinical benefit rate (CBR) was defined as the percentage of participants that had Stable Disease (SD), complete response (CR), or partial response (PR) for greater than or equal to 6 months if there was no evidence of progression at or before assessment performed on or after Study Day 161.
CR= Disappearance of all target lesions.
No new lesions.
PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started.
Physical examination, radiological assessment, and bone scans (if applicable) were used to assess outcome.
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Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
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Number of Participants With Complete Response (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD)
Time Frame: Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
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Table represents the best response achieved over this time frame.
CR = Disappearance of all target lesions.
No new lesions.
PR = At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started.
Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
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Number of Participants With Best Overall Response
Time Frame: Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
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Best overall response rate (ORR) = number of participants with measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) having a best response of complete response (CR) or partial response (PR) divided by number of randomized participants.
RECIST 1.1 response criteria applies.
To be recorded as best response, CR or PR had to be confirmed at ≥ 4 weeks interval.
An unconfirmed CR was recorded as PR.
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Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
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Number of Participants With Serious Adverse Events, Death, and Discontinuation Due to Adverse Events
Time Frame: Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
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Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
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Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
August 29, 2008
First Submitted That Met QC Criteria
September 16, 2008
First Posted (Estimate)
September 17, 2008
Study Record Updates
Last Update Posted (Estimate)
May 26, 2016
Last Update Submitted That Met QC Criteria
May 25, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protein Kinase Inhibitors
- Hormone Antagonists
- Estrogen Antagonists
- Estrogen Receptor Antagonists
- Fulvestrant
- Dasatinib
Other Study ID Numbers
- CA180-158
- USOR 06-030
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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