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:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00248170
First received: November 2, 2005
Last updated: April 26, 2013
Last verified: April 2013
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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: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (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
Show 259 Study LocationsSponsors 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: | April 26, 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 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 Adjuvants, Immunologic Letrozole Anastrozole Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal |
ClinicalTrials.gov processed this record on May 16, 2013