Advanced Breast Cancer Clinical Trial
Official title:
A Double Blind, Double Dummy, Randomised, Multicentre Study to Compare the Efficacy and Safety of Fulvestrant 250mg With Arimidex 1mg as a Secondary-line Therapy in the Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer
| Verified date | January 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.
| Status | Completed |
| Enrollment | 234 |
| Est. completion date | September 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Postmenopausal advanced breast cancer with oestrogen receptor positive - Progression under first-line anti-oestrogen therapy. Exclusion Criteria: - Life-threatening metastasis; contraindication to anastrozole - >2 regimens of hormonotherapy for advanced breast cancer |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Research Site | Beijing | |
| China | Research Site | Dalian | |
| China | Research Site | Fuzhou | |
| China | Research Site | Guangzhou | |
| China | Research Site | Hankou | |
| China | Research Site | He Fei | |
| China | Research Site | Huangzhou | |
| China | Research Site | Ji Nan | |
| China | Research Site | Nanjing | |
| China | Research Site | Shanghai | |
| China | Research Site | Wuhan | |
| China | Research Site | Xi AN |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to Disease Progression (TTP) | |||
| Secondary | Objective Response Rate (ORR) | |||
| Secondary | Clinical Benefit Rate (CBR) | |||
| Secondary | Time to Treatment Failure (TTF) | |||
| Secondary | Safety & Tolerability. |
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