We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00248170
First Posted: November 3, 2005
Last Update Posted: April 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
November 2, 2005
November 3, 2005
September 8, 2015
October 9, 2015
April 19, 2016
December 2005
September 2014   (Final data collection date for primary outcome measure)
Disease Free Survival [ Time Frame: 84 months ]
Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.
Not Provided
Complete list of historical versions of study NCT00248170 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: 84 months ]
    Overall survival was defined as the time from the date of randomization to the date of death from any cause.
  • Time to Development of Distant Metastases [ Time Frame: 84 months ]
    Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast.
  • Time to Development of Contra Lateral Breast Cancer [ Time Frame: 84 months ]
    Time to development of contra lateral breast cancer was defined as the time from the date of randomization to the date of the first development of any disease in the contra lateral breast.
  • Distant Disease-free Survival [ Time Frame: 84 months ]
    Distant disease-free survival was defined as the time from date of randomization to the date of the first development of any relapse at a distant site or death from any cause.
  • Change From Baseline in Serum Lipid Profiles [ Time Frame: baseline, 6, 12, 24, 36, 48 and 60 months ]
    Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.
  • Percentage of Participants Who Experienced Clinical Fracture Events [ Time Frame: 84 months ]
    The incidence of clinical fractures was analyzed.
  • Percentage of Participants Who Experienced Cardiovascular Events [ Time Frame: 84 months ]
    The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.
Not Provided
Not Provided
Not Provided
 
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Letrozole
    2.5 mg tablets
  • Drug: Anastrozole
    1 mg tablets
  • Experimental: Letrozole
    2.5 mg by mouth (p.o.) once daily
    Intervention: Drug: Letrozole
  • Active Comparator: Anastrozole
    1 mg p.o. once daily
    Intervention: Drug: Anastrozole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4172
September 2014
September 2014   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: Female
33 Years to 96 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Canada,   China,   Denmark,   France,   Germany,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Norway,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Finland,   New Zealand
 
NCT00248170
CFEM345D2411
2005-004263-35 ( EudraCT Number )
EUDRACT number 2005-004263-35 ( Registry Identifier: EUDRACT )
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP