A Study of Letrozole in the Treatment of Metastatic Breast Cancer in Combination With Chemotherapy
Phase 2/Phase 3
65 Years
N/A
65 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer
Female
Metastatic Breast Cancer
Trial Information
A Study of Letrozole in the Treatment of Metastatic Breast Cancer in Combination With Chemotherapy
Inclusion Criteria
Inclusion criteria
- Histologically proven metastatic breast cancer
- Measurable disease, patients with bone only disease are not eligible
- Age ≥ 65 years
- Performance status ≤ 2 (World Health Organization)
- Estimated life expectancy under therapy of at least 3 months
- Estrogen-/progesterone-receptor status positive or unknown
- Signed informed consent
Exclusion criteria
- Prior chemo- or hormone therapy for metastatic breast cancer; prior therapy with
aromatase inhibitors in the adjuvant setting
- Disease-free interval after adjuvant therapy < 1 year
- Clinical signs of central nervous system metastases
- Renal, bone marrow, or liver insufficiency
- Severe coronary heart disease, cardiac insufficiency or other severe concomitant
internal diseases
- Pulmonary fibrosis/alveolitis Additional protocol-defined inclusion/exclusion
criteria may apply.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response rate (complete remission, partial remission,no change, progressive disease) by clinical palpation and radiologic imaging every 3 months until disease progression
Principal Investigator
Novartis
Investigator Role:
Study Chair
Investigator Affiliation:
Novartis
Authority:
United States: Food and Drug Administration
Study ID:
CFEM345ADE07
NCT ID:
NCT00333047
Start Date:
July 2002
Completion Date:
Related Keywords:
- Metastatic Breast Cancer
- Metastatic breast cancer
- Aromatase inhibitor
- Letrozole
- Breast Neoplasms
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