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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00754325
First received: August 29, 2008
Last updated: May 25, 2016
Last verified: May 2016
  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 2

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:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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 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) ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 100
Study Start Date: September 2008
Study Completion Date: January 2014
Primary Completion Date: November 2011 (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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arizona
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States, 86336-4937
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, 34667-6594
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-Central Austin Cancer Center
Austin, Texas, United States, 78731
Texas Oncology, P.A.
Bedford, Texas, United States, 76022
Texas Oncology, P.A.
Dallas, Texas, United States, 75230-2510
Texas Oncology
Dallas, Texas, United States, 75231
Texas Oncology Sammons Cancer Center
Dallas, Texas, United States, 75246
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
Quest Diagnostic Clinical Laboratories Inc
Houston, Texas, United States, 77072
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, 77598-4420
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Oncology & Hematology Associates Of Southwest Virginia, Inc.
Salem, Virginia, United States, 24153
Virginia Center Specialists, Pc
Woodbridge, Virginia, United States, 22191
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: 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
Results First Received: May 16, 2016
Last Updated: May 25, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Estradiol
Fulvestrant
Dasatinib
Aromatase Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Estrogens
Steroid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 26, 2016