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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Breast Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-09-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Disease Progression (PD) or Death
timeFrame: 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:
measure: Median Time of Progression-free Survival (PFS)
timeFrame: Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
measure: Percentage of Participants With Progression Free Survival (PFS) at 6 Months
timeFrame: at 6 months
measure: Percentage of Participants With Clinical Benefit for At Least 6 Months
timeFrame: Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
measure: Number of Participants With Complete Response (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD)
timeFrame: Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
measure: Number of Participants With Best Overall Response
timeFrame: Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
measure: Number of Participants With Serious Adverse Events, Death, and Discontinuation Due to Adverse Events
timeFrame: Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
Other outcomes:
Locations:
city: Sedona
country: United States
facility: Northern Arizona Hematology & Oncology Associates
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
state: Arizona
city: Hudson
country: United States
facility: Florida Cancer Institute - New Hope
state: Florida
city: Ocoee
country: United States
facility: Cancer Centers Of Florida, P.A
state: Florida
city: Carmel
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Cancer Center, Llc.
state: Kansas
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Troy
country: United States
facility: New York Oncology Hematology, Pc
state: New York
city: Raleigh
country: United States
facility: Raleigh Hematology Oncology Associates
state: North Carolina
city: Eugene
country: United States
facility: Willamette Valley Cancer Center
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Austin
country: United States
facility: Texas Oncology-Central Austin Cancer Center
state: Texas
city: Bedford
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Oncology Sammons Cancer Center
state: Texas
city: Denton
country: United States
facility: Texas Cancer Center
state: Texas
city: El Paso
country: United States
facility: El Paso Cancer Treatment Ctr - West
state: Texas
city: Houston
country: United States
facility: Us Oncology Research, Inc.
state: Texas
city: Houston
country: United States
facility: Quest Diagnostic Clinical Laboratories Inc
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers Of South Texas
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Waco
country: United States
facility: Texas Oncology Cancer Care And Research Center
state: Texas
city: Webster
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Salem
country: United States
facility: Oncology & Hematology Associates Of Southwest Virginia, Inc.
state: Virginia
city: Woodbridge
country: United States
facility: Virginia Center Specialists, Pc
state: Virginia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: