Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Anastrozole (ARIMIDEX™), Arimidex, ZD1033
Anastrozole · 16 trials · 6 indications
To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of disease-free survival.
Progression Free Survival (PFS) is defined as the interval, in months, from the date of first treatment to the date of disease progression or death, whichever occurred first.
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.
ORR was determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rates. * CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks. * PR = ≥ 50% decrease in tumor size for at least 4 weeks, without any new lesion or any ≥ 25% increase in size of any lesion. All measurements by ruler or calipers.
| Arm | Type | Description |
|---|---|---|
| Arm A: Anastrozol | EXPERIMENTAL | 1 mg per day for 2 years |
| Arm B: Anastrozol | EXPERIMENTAL | 1 mg per day for 5 years |
| 1 | ACTIVE_COMPARATOR | Arimidex 1mg + Nolvadex placebo |
| 2 | ACTIVE_COMPARATOR | Arimidex placebo + Nolvadex 20mg |
| 3 | ACTIVE_COMPARATOR | Arimidex 1mg + Nolvadex 20mg |
| Bevacizumab/anastrozole | EXPERIMENTAL | Bevacizumab 10mg/kg IV every 2 weeks \[patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)\] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles. |
| Bevacizumab/fulvestrant | EXPERIMENTAL | Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks \[patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)\] fulvestrant (500 mg IM on Day 1 of Cycle 1, followed by 250 mg IM of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg IM of fulvestrant). Treatment will be given in 4-week cycles. |
| 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. |
| Anastrozole + Goserelin | EXPERIMENTAL | Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily. No dose attenuation or escalation was allowed for either goserelin or anastrozole. |
| Name | Type | Description |
|---|---|---|
| Anastrozole | DRUG | 1mg tablet daily |
| ARIMIDEX (anastrazole) | DRUG | - |
| NOLVADEX (tamoxifen) | DRUG | - |
| Tamoxifen | DRUG | 20mg, orally, once daily |
| Anastrozole (Arimidex) | DRUG | 1mg, orally, once daily |
| Tamoxifen (Nolvadex) | DRUG | 20mg, orally, once daily |
| Nolvadex placebo | DRUG | - |
| Arimidex placebo | DRUG | - |
| Bevacizumab | DRUG | Bevacizumab 10mg/kg IV every 2 weeks |
| Fulvestrant | DRUG | fulvestrant (500 mg IM on Day 1 of Cycle 1, followed by 250 mg IM of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg IM of fulvestrant). |
| Arimidex | DRUG | Aromatase inhibitors |
| Faslodex | DRUG | Hormone Receptor |
| Anastrozole (ARIMIDEX™) | DRUG | - |
| Arimidex 1 mg | DRUG | Arimidex (anastrozole) 1mg once daily by mouth |
| Anastrozole and goserelin | DRUG | - |
| Goserelin (Zoladex) | DRUG | Goserelin is a palliative treatment of advanced breast cancer in pre- and perimenopausal women |
Inclusion criteria: 1. Postmenopausal patients with histologically confirmed, local radically treated invasive or minimal-invasiv Mammacarcinom with or without previous chemotherapie and/or radiotherapie. 2. No distant metastasis at randomization 3. No relapse at randomization 4. TNM- classificatio...
Anastrozole is used in the treatment of breast cancer and breast neoplasms, and has also been studied in bone density, gynecomastia, and quality of life. It is a small molecule developed by AstraZeneca PLC (ticker AZN) and has been evaluated in Phase 3 clinical trials.
Anastrozole targets CYP19A1 and acts as an inhibitor. By inhibiting this target, it belongs to the endocrine therapeutic area. This mechanism underlies its evaluation across the breast cancer and related indications studied in its clinical program.
Anastrozole is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is listed as the developer of the drug across its clinical trial program.
Anastrozole has been studied in Phase 3 clinical trials. Its trial program includes 8 trials in total, of which 6 are completed and none are currently active, with a combined enrollment of 14,793 participants.
Anastrozole has been evaluated in several Phase 3 trials, including the ATAC sub-protocols: NCT00814125 in breast cancer, NCT00784940 in bone density, NCT00784862 covering pharmacokinetics in breast cancer, and NCT00784680 in quality of life. All four listed trials are completed.
Yes, anastrozole is also known as ARIMIDEX and Arimidex, and is sometimes referenced as anastrozole and goserelin. These names refer to the same drug developed by AstraZeneca PLC.