| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00605267 | Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment | PHASE3 | COMPLETED | 197 | — | — | Oct 1, 2007 | Dec 1, 2010 | Sep 6, 2012 | 4 | Japan |
| NCT00259090 | Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer | PHASE2 | COMPLETED | 120 | — | — | Apr 1, 2004 | Oct 1, 2008 | Aug 16, 2012 | 1 | United Kingdom |
| NCT00255463 | Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study | PHASE2 | COMPLETED | 185 | — | — | Jan 1, 2004 | Nov 1, 2005 | Apr 23, 2009 | 34 | Czechia, France +5 |
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...