Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tamoxifen (Nolvadex)
Tamoxifen · 4 trials · 2 indications
The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from calliper measurement). CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by Calliper: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from ultra sound (US) measurement). CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by US: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period(based on the data from magnetic resonance imaging (MRI) or computed tomography (CT) measurement). CR (or PR) criteria are met at either 12 weeks or 24 weeks. Per RECIST Criteria (V1.0) and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Arm | Type | Description |
|---|---|---|
| Group I | EXPERIMENTAL | Tamoxifen alone |
| Group II | EXPERIMENTAL | Tamoxifen + Aminoglutethimide |
| 1 | ACTIVE_COMPARATOR | Tamoxifen |
| 2 | EXPERIMENTAL | Anastrazole (Arimidex) |
| Name | Type | Description |
|---|---|---|
| Tamoxifen alone | DRUG | 2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years |
| Tamoxifen + Aminoglutethimide | DRUG | 2 x 20 mg tamoxifen daily (5 years) plus Aminoglutethimide daily (first 2 years) * 1st therapy week:125mg/-/125mg Aminoglutethimide daily * 2nd therapy week: 125mg/-/250mg Aminoglutethimid daily * as of 3rd therapy week: 250mg/-/250mg Aminoglutethimid daily |
| Tamoxifen | DRUG | 20 mg once daily oral dose |
| Anastrazole (Arimidex) | DRUG | 1 mg once daily oral dose |
| Goserelin acetate (Zoladex) | DRUG | 3.6mg/month depot injection |
| Anastrozole | DRUG | - |
Inclusion Criteria: * Postmenopausal patients with histologically verified, locoradically treated, invasive or minimally invasive breast cancer * Hormone receptor-positive status * More than 6 histologically examined lymph nodes * Laboratory parameters 1. hematopoiesis: \> 3500/µl leucocytes, \>...
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