Breast Cancer Metastasis
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Genders Eligible for Study: Female Inclusion Criteria: Biopsy confirmation of breast cancer. Evidence of breast cancer that is not considered amenable to curative treatment. Postmenopausal women. Written informed consent to participate in the study. Exclusion Criteria: Previous treatment with hormonal therapy unless that therapy was tamoxifen for adjuvant breast cancer. The use of tamoxifen must have ceased at least one year before this study. Previous treatment with Faslodex. Any existing serious disease, illness, or condition that will prevent participation or compliance with the study procedures. Treatment with an investigational or non-approved drug within one month of then start of the study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Primary Outcome Measures: Time to disease progression (TTP) Secondary Outcome Measures: Objective response rate (ORR), Duration of response (DoR), Time to treatment failure (TTF), Overall survival (OS), Quality of Life (QOL) and Tolerability. | — |