Status:
COMPLETED
Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy
Lead Sponsor:
Novartis
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
65+ years
Phase:
PHASE2
PHASE3
Brief Summary
Therapeutic interventions for patients with metastatic breast cancer are aimed at prolonging survival and improving the quality of life. The objective of this trial is to assess if an initial chemothe...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00333047
Start Date
July 1 2002
Last Update
November 19 2009
Active Locations (1)
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1
Kiel, Germany