Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Arimidex · 4 trials · 4 indications
The primary endpoint is change in Ki-67 levels from baseline (pre) to day 28 (post) biopsy samples. Ki-67 levels were log-transformed to achieve approximately normally distributed data. The differences in these log-transformed values between post vs. pre biopsy samples were calculated. This difference represents the log of the ratio of post vs. pre Ki-67 levels in the original scale.
By assessment of AUC and Cmax of anastrozole after a single oral administration of each anastrozole formulation.
| Arm | Type | Description |
|---|---|---|
| ARM A / Arimidex with Faslodex | ACTIVE_COMPARATOR | Arimidex with Faslodex in postmenopausal women |
| ARM B Arimidex without Faslodex | ACTIVE_COMPARATOR | Arimidex without Faslodex in postmenopausal women. |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | 2 way crossover |
| 3 | EXPERIMENTAL | 2 way crossover |
| 4 | EXPERIMENTAL | 2 way crossover |
| Name | Type | Description |
|---|---|---|
| ARIMIDEX (anastrazole) | DRUG | - |
| NOLVADEX (tamoxifen) | DRUG | - |
| Arimidex | DRUG | Aromatase inhibitors |
| Faslodex | DRUG | Hormone Receptor |
| Arimidex 1 mg | DRUG | Arimidex (anastrozole) 1mg once daily by mouth |
| Anastrozole ODF | DRUG | Each volunteer will receive a single dose of Anastrozole ODF with water. |
| Arimidex tablet | DRUG | Each volunteer will receive a single dose of Arimidex tablet with water |
Inclusion Criteria: * Operable or potentially operable breast cancer * Invasive breast cancer proven to be hormone-sensitive (ER+/PR+) * Patients who might benefit from endocrine treatment prior to surgery * Postmenopausal * Signed written informed consent Exclusion Criteria: * Inoperable breast ...
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Arimidex is used for breast cancer, specifically in postmenopausal women with hormone receptor positive breast cancer, and for McCune-Albright syndrome. It is also studied for safety and pharmacokinetics. Arimidex is developed by AstraZeneca PLC and is an investigational small molecule in clinical development.
Arimidex is an aromatase inhibitor, a small molecule that works by blocking the aromatase enzyme, which is involved in estrogen production. By reducing estrogen levels, it helps treat hormone receptor positive breast cancer. This mechanism is relevant to its use in postmenopausal women with breast cancer.
Arimidex is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate Arimidex for various indications, including breast cancer and McCune-Albright syndrome.
Arimidex is in Phase 3 clinical development, based on the PROACT trial (NCT00232661) which is a Phase 3 study. It is not FDA approved and remains investigational. Other trials include Phase 2 studies for McCune-Albright syndrome and breast cancer, and a Phase 1 bioequivalence study.
Arimidex has been studied in several clinical trials, including NCT00055302 for McCune-Albright syndrome, NCT00232661 (PROACT) for breast cancer, NCT00570323 for breast cancer with or without Faslodex, and NCT01568281 for safety and pharmacokinetics. All trials are completed, with a total enrollment of 524 participants.
Arimidex is a brand name for anastrozole. The bioequivalence study NCT01568281 compared Arimidex tablets to anastrozole ODF in healthy subjects, confirming that Arimidex contains the active ingredient anastrozole. This information helps clarify the relationship between the brand and generic names.