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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00248170
First received: November 2, 2005
Last updated: March 20, 2016
Last verified: March 2016
  Purpose
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 Intervention Phase
Breast Cancer
Drug: Letrozole
Drug: Anastrozole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Disease Free Survival [ Time Frame: 84 months ] [ Designated as safety issue: No ]
    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:
  • Overall Survival [ Time Frame: 84 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The incidence of clinical fractures was analyzed.

  • Percentage of Participants Who Experienced Cardiovascular Events [ Time Frame: 84 months ] [ Designated as safety issue: Yes ]
    The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.


Enrollment: 4172
Study Start Date: December 2005
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   33 Years to 96 Years   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248170

  Show 263 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00248170     History of Changes
Other Study ID Numbers: CFEM345D2411  2005-004263-35  EUDRACT number 2005-004263-35 
Study First Received: November 2, 2005
Results First Received: September 8, 2015
Last Updated: March 20, 2016
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: The Austrian Agency for Health and Food Safety (AGES)
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada (Therapeutic Products Directorate - TPD)
China: State Food and Drug Administration (SFDA)
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Agence francaise de securite sanitaire des produits de sante
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
Israel: Ministry of Health
Italy: Agenzia Italiana del Farmaco
Japan: Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA)
South Korea: Korea Food and Drug Administration (KFDA)
Netherlands: Medicines Evaluation Board (MEB)
New Zealand: Medsafe - Medicines and Medical Defices Safety Authority
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency (MPA)
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
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

ClinicalTrials.gov processed this record on December 07, 2016