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Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer

Thank you

Trial Information

Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic


Inclusion Criteria:



- Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable
locally recurrent or metastatic disease

- Has measurable or evaluable-only disease

- Is female, ≥18 yrs of age, post menopausal or surgically sterile

- HER2 negative, HR+, ER+ and/or PgR+ breast cancer

- 0-1 prior chemotherapy regimen for metastatic disease.

- Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior

- Prior tamoxifen therapy is allowed

- No AI therapy for >1 year without recurrence

Exclusion Criteria:

- Pregnant or breast feeding

- Prior hormonal therapy for metastatic or locally recurrent disease

- >1 chemotherapy regimen for metastatic 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:

Determine the clinical benefit rate with letrozole or with letrozole plus dasatinib

Outcome Time Frame:

(CBR equal to CR+PR+SD ≥6 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:

CA180-185

NCT ID:

NCT00696072

Start Date:

October 2008

Completion Date:

February 2015

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

Name

Location

Virginia Oncology AssociatesNewport News, Virginia  23606
Rocky Mountain Cancer CentersThornton, Colorado  80260
Tyler Cancer CenterTyler, Texas  75702
Cancer Care NorthwestSpokane, Washington  99202
Willamette Valley Cancer CenterEugene, Oregon  97401-8122
Local InstitutionChicago, Illinois  
Local InstitutionBronx, New York  
Local InstitutionCincinnati, Ohio  
Local InstitutionVancouver, Washington  
Texas OncologyDallas, Texas  
Local InstitutionPhoenix, Arizona  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionNew Brunswick, New Jersey  
Local InstitutionAustin, Texas  
Medical Oncology AssociatesKingston, Pennsylvania  18704
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Texas Cancer Center at Medical CityDallas, Texas  75230
Dayton Oncology and HematologyKettering, Ohio  
Local InstitutionColumbia, Missouri  
Northern Arizona Hematology & Oncology AssociatesSedona, Arizona  86336
New York Oncology Hematology, PCAlbany, New York  12208
Oncology & Hematology Associates of Southwest Virginia, Inc.Salem, Virginia  24153
Cancer Care Centers of South TexasSan Antonio, Texas  78229
Yakima Valley Memorial Hospital/North Star LodgeYakima, Washington  98902
Texas Oncology Cancer Care and Research CenterWaco, Texas  76712
Florida Cancer Institute - New HopeNew Port Richey, Florida  34655
Northwest Cancer Specialists, PCPortland, Oregon  97225
Arizona Oncology Associates D.B.A. Hematology OncologyTucson, Arizona  85704
Texas Oncology-Central Austin Cancer CenterAustin, Texas  78731
Texas Oncology Sammons Cancer CenterDallas, Texas  75246
UsorDallas, Texas  75246
El Paso Cancer Treatment Ctr - EastEl Paso, Texas  79915
Texas Oncology-Plano EastPlano, Texas  75075