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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00248170
First received: November 2, 2005
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer and were randomized to this study. Patients randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up and collection of antineoplastic and hormonal (endocrine) therapies taken since discontinuation of study drug will continue until 959 disease free events have been observed but no later than approximately April 2018. There will be no study drug administered during this follow-up.


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: A Randomized, Multi-center, Phase IIIb, Open Label Study of Letrozole vs 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:
  • Compare rate of disease free survival betwen the two treatment arms when 959 DFS events have occurred, but no later than approximately April 2018 [ Time Frame: 959 events or approximately April 2018 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the general safety between the two treatment arms [ Time Frame: 959 events or approximately April 2018 ] [ Designated as safety issue: Yes ]
  • Compare the efficacy of the two treatment arms for overall survival [ Time Frame: 959 events or approximately April 2018 ] [ Designated as safety issue: No ]
  • Compare the efficacy of the two treatment arms for time to development of distant metastases [ Time Frame: 959 events or approximately April 2018 ] [ Designated as safety issue: No ]
  • Compare the efficacy of the two treatment arms for breast cancer specific survival [ Time Frame: 959 events or approximately April 2018 ] [ Designated as safety issue: No ]
  • Compare the effect of treatment on serum lipid profiles between treatment arms, and [ Time Frame: 959 events or approximately April 2018 ] [ Designated as safety issue: Yes ]
  • Describe the incidence of bone fractures in each treatment arm [ Time Frame: 959 events or approximately April 2018 ] [ Designated as safety issue: Yes ]

Enrollment: 4160
Study Start Date: December 2005
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letrozole Drug: Letrozole
Active Comparator: Anastrozole Drug: Anastrozole

  Eligibility

Ages Eligible for Study:   33 Years and older
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 260 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( 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
Last Updated: May 19, 2014
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
Letrozole
Anastrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on July 23, 2014