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OpenTrials
Completed

NCT Number: NCT00248170

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

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.

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Key information

Age range

33 year–96 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Garran, Australian Capital Territory, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

letrozole

Drug

2.5 mg tablets

Anastrozole

Drug

1 mg tablets

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Acronym: FACE

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
Nov 3, 2005
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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