Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy

Novartis

Status and phase: Completed; Phase 3; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: Letrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00333047

CFEM345ADE07

Details and patient eligibility

About

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 chemotherapy followed by an endocrine therapy leads to a longer disease-free interval as compared to chemotherapy alone.

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)