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Also known as Arimidex tablet, ARIMIDEX (anastrazole), Anastrozole, ZD1033, Anastrazole (Arimidex), Anastrozole (Arimidex), Anastrazole, Anastozole (Arimidex)
Arimidex · 17 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 | - |
| Anastrazole | DRUG | - |
| Gefitinib | 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...
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Arimidex is a small molecule medicine developed by AstraZeneca PLC (ticker AZN) for breast cancer and McCune-Albright Syndrome. It is an oral tablet, including a 1 mg dose form. Arimidex has been studied in Phase 2 and Phase 3 clinical trials, including active-controlled and double-blind studies.
Arimidex is used for breast cancer, including hormone receptor positive disease in postmenopausal women. It has been studied both alone and with Faslodex in HR positive breast cancer, and compared with tamoxifen in the pre-operative setting. Arimidex is also studied in McCune-Albright Syndrome.
Arimidex is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the company behind the Arimidex clinical development program in breast cancer and McCune-Albright Syndrome.
Arimidex has been studied in Phase 3 clinical development, with Phase 3 and Phase 2 trials completed. The Phase 3 PROACT trial compared pre-operative Arimidex with tamoxifen. Arimidex is an investigational therapy in the studies described here and is not stated to be approved for these uses.
Arimidex has been evaluated in trials including NCT00570323, which tested Arimidex with or without Faslodex in postmenopausal women with HR positive breast cancer, NCT00232661 (PROACT), which compared pre-operative Arimidex with tamoxifen, and NCT00055302, which studied Arimidex in McCune-Albright Syndrome.
Yes, Arimidex is also known as anastrazole, and is marketed in forms such as the Arimidex tablet and Arimidex 1 mg. Searches for Arimidex 1 mg or ARIMIDEX (anastrazole) refer to the same AstraZeneca product.