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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate progression-free survival (PFS) distribution of subjects with advanced breast cancer treated with either fulvestrant plus dasatinib or single-agent fulvestrant

Outcome Time Frame:

6 months and 12 months

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-158

NCT ID:

NCT00754325

Start Date:

September 2008

Completion Date:

December 2012

Related Keywords:

  • Advanced Breast Cancer
  • Breast Neoplasms

Name

Location
Texas Oncology, P.A. Dallas, Texas  75246
Virginia Oncology Associates Newport News, Virginia  23606
Missouri Cancer Associates Columbia, Missouri  65201
Tyler Cancer Center Tyler, Texas  75702
Willamette Valley Cancer Center Eugene, Oregon  97401-8122
Texas Oncology Dallas, Texas  
Central Indiana Cancer Centers Indianapolis, Indiana  46227
Minnesota Oncology Hematology, P.A. Minneapolis, Minnesota  55407
Texas Cancer Center Abilene, Texas  79606
Raleigh Hematology Oncology Associates Cary, North Carolina  27511
Northern Arizona Hematology & Oncology Associates Sedona, Arizona  86336
New York Oncology Hematology, PC Albany, New York  12208
Oncology & Hematology Associates of Southwest Virginia, Inc. Salem, Virginia  24153
Cancer Care Centers of South Texas San Antonio, Texas  78229
Northwest Cancer Specialists, P.C. Portland, Oregon  97227
Texas Oncology Cancer Care and Research Center Waco, Texas  76712
Florida Cancer Institute - New Hope New Port Richey, Florida  34655
US Oncology Research, Inc. Dallas, Texas  75204
Cancer Centers Of Florida, P.A Ocoee, Florida  34761
Texas Oncology Sammons Cancer Center Dallas, Texas  75246
Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope Tucson, Arizona  85704
Kansas City Cancer Center, Llc. Overland Park, Kansas  66210
Texas Oncology-Austin Central Austin, Texas  78731
El Paso Cancer Treatment Ctr - West El Paso, Texas  79902
Virginia Center Specialists, Pc Fairfax, Virginia  22031