Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Anastrazole · 3 trials · 1 indication
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.
For each sample, the ER H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = \[(0.5 x percent +/-) + (1 x percent +) + (2 x percent ++) + (3 x percent +++)\]. Range 0-300. The greater the change from baseline (randomization) in ER H-score, the greater the blockage of ER expression and the greater the potential anti-tumour activity. Percentage change from baseline=\[(SRG - BL)/BL\]x100
For each sample, the PgR H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = \[(0.5 x percent+/-) + (1 x percent+) + (2 x percent++) + (3 x percent+++)\]. Range 0-300. The greater the change from baseline (randomization in PgR H-score, the greater the blockage of PgR expression and the greater the potential anti-tumour activity. Percentage change from baseline=\[(SRG - BL)/BL\]x100
For each sample, the Ki67 labelling index is calculated as the percentage of cells stained positive for Ki67. Range 0-100. The greater the change from baseline (randomization) in Ki67 labelling index, the greater the blockage of Ki67 expression and the greater the potential anti-tumour activity. Percentage change from baseline=\[(SRG - BL)/BL\]x100
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Tamoxifen |
| 2 | EXPERIMENTAL | Anastrazole (Arimidex) |
| 3 | EXPERIMENTAL | Anastrozole + Fulvestrant |
| Name | Type | Description |
|---|---|---|
| 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 |
| Fulvestrant | DRUG | 500 mg intramuscular injection |
| Anastrazole | DRUG | oral tablet |
| Gefitinib | DRUG | - |
Inclusion Criteria: * Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided written informed consent Exclusion Criteria: * Medical history of chemotherapy or endocrine therapy for breast cancer, or with treatment hist...
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Anastrazole is used for breast cancer. It is an investigational small molecule being studied in postmenopausal and premenopausal women with breast cancer, including as a neoadjuvant treatment before surgery. The drug is being developed by AstraZeneca PLC (AZN) and is currently in Phase 3 clinical development.
Anastrazole is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials of the drug in breast cancer patients across multiple countries, including the United Kingdom, Japan, and several European nations.
Anastrazole is in Phase 3 clinical development for breast cancer. While the drug has completed three trials, including one Phase 3 study, it remains investigational and has not been approved by regulatory authorities. The Phase 3 trial enrolled 197 premenopausal patients in Japan.
Anastrazole has been studied in three completed clinical trials: NCT00255463, a Phase 2 neoadjuvant study in ER+/PgR+ breast cancer with 185 patients; NCT00259090, a Phase 2 study of Faslodex alone or with Anastrazole in 120 postmenopausal women; and NCT00605267, a Phase 3 neoadjuvant study in 197 premenopausal patients.
Yes, Anastrazole is also known as Arimidex. Clinical trial titles reference Arimidex, such as the Phase 2 study 'Arimidex +/- Iressa' and the Phase 3 study 'Arimidex/Tamoxifen Neo Adjuvant Study.' These names refer to the same drug being developed by AstraZeneca.
Anastrazole is an aromatase inhibitor that works by reducing estrogen production in the body. It is being studied in hormone receptor-positive breast cancer, where estrogen can drive tumor growth. By lowering estrogen levels, the drug aims to slow or stop cancer cell proliferation.