Metastatic Breast Cancer
Conditions
Keywords
Metastatic breast cancer, Aromatase inhibitor, Letrozole
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 chemotherapy followed by an endocrine therapy leads to a longer disease-free interval as compared to chemotherapy alone.
Interventions
DRUGLetrozole
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (complete remission, partial remission,no change, progressive disease) by clinical palpation and radiologic imaging every 3 months until disease progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression and safety and toxicity during treatment | — |
Countries
Germany
Outcome results
None listed