Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Anastrozole (ARIMIDEX™), Anastrozole and goserelin, Anastrozole (Arimidex)
Anastrozole · 13 trials · 5 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.
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. |
| 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 |
| 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). |
| Anastrozole (ARIMIDEX™) | DRUG | - |
| 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...