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
- Registration Number
- NCT00754325
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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)
- Pregnant or breast feeding
- >1 chemotherapy regimen for advanced disease
- Pleural or pericardial effusion
- Serious cardiac condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 (Dasatinib +Fulvestrant) Dasatinib - Arm 1 (Dasatinib +Fulvestrant) Fulvestrant - Arm 2 (Fulvestrant) Fulvestrant -
- Primary Outcome Measures
Name Time Method Number of Participants With Disease Progression (PD) or Death 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.
- Secondary Outcome Measures
Name Time Method 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) 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.
Number of Participants With Serious Adverse Events, Death, and Discontinuation Due to Adverse Events Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) 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.
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) 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.
Percentage of Participants With Progression Free Survival (PFS) at 6 Months at 6 months 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.
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) 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.
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) 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.
Trial Locations
- Locations (26)
Kansas City Cancer Center, Llc.
🇺🇸Overland Park, Kansas, United States
Northern Arizona Hematology & Oncology Associates
🇺🇸Sedona, Arizona, United States
Us Oncology Research, Inc.
🇺🇸Houston, Texas, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
El Paso Cancer Treatment Ctr - West
🇺🇸El Paso, Texas, United States
Raleigh Hematology Oncology Associates
🇺🇸Raleigh, North Carolina, United States
Minnesota Oncology Hematology, P.A.
🇺🇸Minneapolis, Minnesota, United States
Texas Oncology Cancer Care And Research Center
🇺🇸Waco, Texas, United States
Central Indiana Cancer Centers
🇺🇸Carmel, Indiana, United States
Northwest Cancer Specialists, P.C.
🇺🇸Portland, Oregon, United States
Cancer Centers Of Florida, P.A
🇺🇸Ocoee, Florida, United States
Texas Cancer Center
🇺🇸Denton, Texas, United States
New York Oncology Hematology, Pc
🇺🇸Troy, New York, United States
Willamette Valley Cancer Center
🇺🇸Eugene, Oregon, United States
Texas Oncology
🇺🇸Dallas, Texas, United States
Cancer Care Centers Of South Texas
🇺🇸San Antonio, Texas, United States
Texas Oncology-Central Austin Cancer Center
🇺🇸Austin, Texas, United States
Oncology & Hematology Associates Of Southwest Virginia, Inc.
🇺🇸Salem, Virginia, United States
Florida Cancer Institute - New Hope
🇺🇸Hudson, Florida, United States
Texas Oncology Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Quest Diagnostic Clinical Laboratories Inc
🇺🇸Houston, Texas, United States
Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
🇺🇸Tucson, Arizona, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Texas Oncology, P.A.
🇺🇸Webster, Texas, United States
Virginia Center Specialists, Pc
🇺🇸Woodbridge, Virginia, United States