TriangleNCT00248170 · CITED IN SOURCE DOCUMENTS
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2016-04-19
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Disease Free Survival
Overall Survival
Time to Development of Distant Metastases
Time to Development of Contra Lateral Breast Cancer
Distant Disease-free Survival
Change From Baseline in Serum Lipid Profiles
Percentage of Participants Who Experienced Clinical Fracture Events
Percentage of Participants Who Experienced Cardiovascular Events
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility 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.
- healthy Volunteers
- false
- maximum Age
- 96 Years
- minimum Age
- 33 Years
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- 2.5 mg by mouth (p.o.) once daily
- intervention Names
- Drug: Letrozole
- label
- Letrozole
- type
- EXPERIMENTAL
- description
- 1 mg p.o. once daily
- intervention Names
- Drug: Anastrozole
- label
- Anastrozole
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Letrozole
- description
- 2.5 mg tablets
- name
- Letrozole
- type
- DRUG
- arm Group Labels
- Anastrozole
- description
- 1 mg tablets
- name
- Anastrozole
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 4172
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Disease Free Survival
- time Frame
- 84 months
- secondary Outcomes
- description
- Overall survival was defined as the time from the date of randomization to the date of death from any cause.
- measure
- Overall Survival
- time Frame
- 84 months
- description
- 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.
- measure
- Time to Development of Distant Metastases
- time Frame
- 84 months
- description
- 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.
- measure
- Time to Development of Contra Lateral Breast Cancer
- time Frame
- 84 months
- description
- 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.
- measure
- Distant Disease-free Survival
- time Frame
- 84 months
- description
- Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.
- measure
- Change From Baseline in Serum Lipid Profiles
- time Frame
- baseline, 6, 12, 24, 36, 48 and 60 months
- description
- The incidence of clinical fractures was analyzed.
- measure
- Percentage of Participants Who Experienced Clinical Fracture Events
- time Frame
- 84 months
- description
- The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.
- measure
- Percentage of Participants Who Experienced Cardiovascular Events
- time Frame
- 84 months
Full study description
- brief Summary
- 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.
Source references
Source notices and limitations
Discovery and provenance
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- r, open label, study of letrozole vs anastrozole in the adjuvant treatment of postmenopausal women with hormone receptor and node positive breast cancer (FACE, NCT00248170), the median duration of treatment was 60 months for both treatment arms. Table 2 describes adverse reactions (Grades 1-4 and Grades 3-4) irrespective of relat
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- age=English'); return(false);">Level of evidence B1</a>]</li></ul></div></li><li>In the Femara Versus Anastrozole Clinical Evaluation (<a href="/clinicaltrials/NCT00248170">FACE</a>) study (NCT00248170), 4,136 patients with hormone receptor–positive disease were randomly assigned to receive either letrozole or anastrozole.[
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- >Level of evidence B1</a>]</li></ul></div></li><li>In the Femara Versus Anastrozole Clinical Evaluation (<a href="/clinicaltrials/NCT00248170">FACE</a>) study (NCT00248170), 4,136 patients with hormone receptor–positive disease were randomly assigned to receive either letrozole or anastrozole.[<a href="#cit/section_6.75">75
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- source title
- Breast Cancer Treatment (PDQ®)–Health Professional Version
- source update dates
- context
- Updated: April 25, 2025
- datetime
- 2025-04-25T12:00:00Z
- display
- April 25, 2025
Preserved source evidence · Not medical advice