Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
faslodex · 1 trial · 1 indication
PFS was defined as the time from randomisation until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), surgery or radiotherapy to manage worsening of disease or death by any cause (in the absence of progression). Outcome measure is reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.
| Arm | Type | Description |
|---|---|---|
| faslodex+placebo | EXPERIMENTAL | Blinded: Fulvestrant 500mg intramuscular injection (2x250mg) plus dummy Anastrozole tablets |
| arimidex +placebo | ACTIVE_COMPARATOR | Blinded: Anastrozole 1mg tablets plus dummy Fulvestrant intramuscular injection (2x0mg) |
| Name | Type | Description |
|---|---|---|
| faslodex 500mg | DRUG | 2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter |
| arimidex 1mg | DRUG | oral tablet 1 daily |
| faslodex dummy | DRUG | 2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter |
| arimidex dummy | DRUG | oral tablet 1 daily |
Inclusion Criteria: * Histological confirmation of breast cancer in post menopausal women (age \>=60). Positive hormone receptor status (ER +ve and/or PgR +ve) of primary or metastatic tumour tissue based on local laboratory assessment. * EITHER locally advanced disease (1 line of chemotherapy allo...
Faslodex is used for the treatment of hormone receptor positive breast cancer. It is an investigational small molecule being developed by AstraZeneca PLC (AZN) and is currently in Phase 3 clinical development.
Faslodex targets the estrogen receptor in hormone receptor positive breast cancer. It is a small molecule designed to interfere with estrogen receptor signaling, which is relevant to the growth of hormone receptor positive tumors.
Faslodex is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN.
Faslodex is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed.
Faslodex has been studied in a Phase 3 clinical trial identified as NCT01602380. This trial compared fulvestrant, the active ingredient in Faslodex, with Arimidex in a subset of patients with hormone receptor positive breast cancer. The trial enrolled 462 female participants and has been completed.
Faslodex is the brand name for fulvestrant. The clinical trial NCT01602380 refers to fulvestrant as the investigational drug, and Faslodex is the proprietary name under which it is being developed.