Breast Neoplasms
Conditions
Keywords
breast cancer, fulvestrant, Faslodex, hormonotherapy, aromatase inhibitor failure, Advanced breast cancer
Brief summary
The primary objective of the study is to assess the activity of fulvestrant in postmenopausal women with advanced breast cancer failing treatment with non-steroidal or steroidal aromatase inhibitors by estimating the Clinical Benefit Rate
Interventions
DRUGFulvestrant
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Histological/cytological confirmation of breast cancer * progression under treatment with an aromatase inhibitor * At least one measurable or non-measurable lesion
Exclusion criteria
* Prior treatment for breast cancer with more than 2 different hormonal agents * More than 1 chemotherapy for advanced disease * Presence of life-threatening metastatic visceral disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Benefit Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | — |
| Duration of response | — |
| Duration of clinical benefit | — |
| Safety and tolerability | — |
| 6. clinical benefit rate according to HER2/neu status | — |
| Time to treatment failure | — |
Countries
Belgium, Switzerland
Outcome results
None listed