Advanced Breast Cancer
Conditions
Keywords
Advanced breast cancer, Faslodex
Brief summary
The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer
Interventions
DRUGFulvestrant
500 mg intramuscular injection
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of written informed consent * Postmenopausal woman who fulfils any one of the following criteria: * Histological or cytological confirmation of breast cancer * Estrogen receptor positive (ER+) or progesterone receptor positive (PgR+).
Exclusion criteria
* Having received any one of the following therapy for advanced or recurrent breast cancer * 2 or more regimens of hormonal therapy or immunotherapy or 2 or more regimens of chemotherapy, etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to assess the tolerability of 500mg fulvestrant | assessed when all patients have been in the study for 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | assessed when all patients have been in the study for 6 months |
| ORR | assessed when all patients have been in the study for 6 months |
| Pharmacokinetics | each visit |
| Time to response | assessed when all patients have been in the study for 6 months |
| duration of response and changes in serum tumour markers | assessed when all patients have been in the study for 6 months |
| Clinical benefit rate | assessed when all patients have been in the study for 6 months |
Countries
Japan
Outcome results
None listed