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: November 11, 2013
Last verified: November 2013
  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
Drug: Letrozole, 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:
  • Compare rate of disease free survival at 5 years between letrozole and anastrozole [ Time Frame: Disease-free survival 320 events and 639 events ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the general safety between the two treatment arms [ Time Frame: Disease-free survival 320 events and 639 events ] [ Designated as safety issue: Yes ]
  • Compare the efficacy of the two treatment arms for overall survival [ Time Frame: Disease-free survival 320 events and 639 events ] [ Designated as safety issue: No ]
  • Compare the efficacy of the two treatment arms for time to development of distant metastases [ Time Frame: Disease-free survival 320 events and 639 events ] [ Designated as safety issue: No ]
  • Compare the efficacy of the two treatment arms for breast cancer specific survival [ Time Frame: Disease-free survival 320 events and 639 events ] [ Designated as safety issue: No ]

Enrollment: 4160
Study Start Date: December 2005
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letrozole Drug: Letrozole Drug: Letrozole, anastrozole
Active Comparator: Anastrozole Drug: Anastrozole Drug: Letrozole, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248170

  Show 259 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: November 11, 2013
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 April 15, 2014