Phase 3
Completed N=4,172
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
Source: ClinicalTrials.gov NCT00248170 ↗Enrolled (actual)
4,172
Serious AEs
24.5%
Results posted
Oct 2015
Primary outcomePrimary: Disease Free Survival — NA; NA Months — p=0.3150
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Free Survival |
NA; NA | 0.3150 |
| SECONDARY Overall Survival |
NA; NA | — |
| SECONDARY Time to Development of Distant Metastases |
NA; NA | — |
| SECONDARY Time to Development of Contra Lateral Breast Cancer |
NA; NA | — |
| SECONDARY Distant Disease-free Survival |
NA; NA | — |
| SECONDARY Change From Baseline in Serum Lipid Profiles |
5.643; 5.553; 5.569; 5.511; 5.508; 5.436 | — |
| SECONDARY Percentage of Participants Who Experienced Clinical Fracture Events |
9.3; 8.1 | — |
| SECONDARY Percentage of Participants Who Experienced Cardiovascular Events |
2.4; 1.5; 1.5; 0.7; 1.6; 1.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00248170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.