Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer


Phase 3
33 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer


Inclusion Criteria:



- Recent primary surgery for breast cancer

- Early stage breast cancer

- Postmenopausal

- Hormone receptor positive

- Positive lymph node involvement

Exclusion Criteria:

- Metastatic disease

- Presence of contralateral breast cancer including DCIS

- Progression

Other protocol-defined inclusion/exclusion criteria may apply.

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:

Compare rate of disease free survival at 5 years between letrozole and anastrozole

Outcome Time Frame:

Disease-free survival 320 events and 639 events

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CFEM345D2411

NCT ID:

NCT00248170

Start Date:

December 2005

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • letrozole
  • anastrozole
  • adjuvant
  • postmenopausal
  • FACE
  • Breast Neoplasms

Name

Location
Texas Oncology, P.A. Dallas, Texas  75246
Aultman Cancer Center Canton, Ohio  44710
Comprehensive Cancer Institute Huntsville, Alabama  35801
Florida Cancer Specialists Fort Myers, Florida  33901
Tyler Cancer Center Tyler, Texas  75702
San Antonio Tumor and Blood Clinic San Antonio, Texas  78217
Wichita Community Clinical Oncology Program Wichita, Kansas  67214-3882
Florida Cancer Institute New Port Richey, Florida  34652
Central Indiana Cancer Centers Indianapolis, Indiana  46227
Allison Cancer Center Midland, Texas  79701
Center for Cancer & Blood Disorders Bethesda, Maryland  20817
Northwest Cancer Specialists, P.C. Vancouver, Washington  
Longview Cancer Center Longview, Texas  75601
Kansas City Cancer Center Kansas City, Kansas  66112
Center for Oncology Research and Treatment, PA Dallas, Texas  75230
Gulfcoast Oncology Associates St. Petersburg, Florida  33705
Birmingham Hematology and Oncology Associates Birmingham, Alabama  35235
El Paso Cancer Treatment Ctr-East El Paso, Texas  79915
Sarah Cannon Research Institute Nashville, Tennessee  37203
MD Anderson Cancer Center/University of Texas Houston, Texas  77030
Oncology & Hematology Associates, PC New London, Connecticut  06320
Northeast Georgia Cancer Care Athens, Georgia  30607
Texas Cancer Center- Sherman Sherman, Texas  75090-0504
Texas Cancer Center ( Medical City Dallas Hospital) Dallas, Texas  75230
Fairfax Northern Virginia Hematology Oncology Fairfax, Virginia  
New York Oncology Hematology, P.C. NYOH Latham Troy, New York  12180
Northern Arizona Hematology/Oncology Associates, P.C. Flagstaff, Arizona  86001
Cancer Centers of Florida PA Ocoee, Florida  34761
St. Louis Cancer & Breast Institute St. Louis, Missouri  63141
Sarah Cannon Oncology Hematology Care, Inc Cincinnati, Ohio  45242
Oncology Associates of Oregon, PC Eugene, Oregon  97401-8122
Medical Oncology Associates of Wyorning Valley, PC Kingston, Pennsylvania  18704
Chattanooga Oncology and Hematology Assoicates, PC Chattanooga, Tennessee  37404
Texas Oncology, P.A. Presbyterian Hospital Dallas, Texas  75246
Texas Oncology, P.A. Sammons Cancer Center Dallas, Texas  75246
Texas Oncology, P.A. Texas Oncology PA Dallas, Texas  75251
Texas Cancer Center Denton Denton, Texas  76210
South Texas Cancer Center- McAllen McAllen, Texas  78503
Waco Cancer and Research Center Waco, Texas  76712