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

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ClinicalTrials.gov Identifier: NCT00248170
Recruitment Status : Completed
First Posted : November 3, 2005
Results First Posted : October 9, 2015
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Letrozole Drug: Anastrozole Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
Study Start Date : December 2005
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Letrozole
2.5 mg by mouth (p.o.) once daily
 Drug: Letrozole
2.5 mg tablets
Active Comparator: Anastrozole
1 mg p.o. once daily
 Drug: Anastrozole
1 mg tablets


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Percentage of Participants Who Experienced Clinical Fracture Events [ Time Frame: 84 months ]
    The incidence of clinical fractures was analyzed.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   33 Years to 96 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248170


  Show 263 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00248170     History of Changes
Other Study ID Numbers: CFEM345D2411
2005-004263-35 ( EudraCT Number )
EUDRACT number 2005-004263-35 ( Registry Identifier: EUDRACT )
First Posted: November 3, 2005    Key Record Dates
Results First Posted: October 9, 2015
Last Update Posted: April 19, 2016
Last Verified: March 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Breast cancer
letrozole
anastrozole
 adjuvant
postmenopausal
FACE

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Letrozole
Anastrozole
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal