Multi-centre, Randomised, Double-blind, Parallel-group Study to Compare Efficacy and Safety Between Anastrozole (ZD1033) and Tamoxifen in Pre- and Post-operative Administration Under Goserelin Acetate Treatment for Premenopausal Breast Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Best Overall Response Rate (BORR) (Calliper)
研究概览
简要总结
The purpose of this multi-centre, randomised, double-blind, parallel-group study is to compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative administration under goserelin acetate treatment for premenopausal breast cancer patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided written informed consent
排除标准
- •Medical history of chemotherapy or endocrine therapy for breast cancer, or with treatment history of radiotherapy. Unwillingness to stop taking any drug known to affect sex hormone status (including hormone replacement therapy (HRT).
研究组 & 干预措施
1
Tamoxifen
干预措施: Tamoxifen (Drug)
1
Tamoxifen
干预措施: Goserelin acetate (Zoladex) (Drug)
2
Anastrazole (Arimidex)
干预措施: Anastrazole (Arimidex) (Drug)
2
Anastrazole (Arimidex)
干预措施: Goserelin acetate (Zoladex) (Drug)
结局指标
主要结局
Best Overall Response Rate (BORR) (Calliper)
时间窗: 24 weeks
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.
Best Overall Response Rate (BORR) (US)
时间窗: 24 weeks
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.
Best Overall Response Rate (BORR) (MRI/CT)
时间窗: 24 weeks
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.
次要结局
- Bone Mineral Density (BMD) Lumbar Spine(Assessed at baseline and after 24 weeks of treatment)
- Bone Turnover Marker (BAP) EIA Method(Assessed at baseline and after 24 weeks of treatment)
- Serum Oestrone (E1) Concentrations(Assessed at baseline and after 24 weeks of treatment)
- Bone Mineral Density (BMD) Cervical Thighbone(Assessed at baseline and after 24 weeks of treatment)
- Bone Turnover Marker (NTX)(Assessed at baseline and after 24 weeks of treatment)
- Serum Oestradiol (E2) Concentrations(Assessed at baseline and after 24 weeks of treatment)
- Human Epidermal Growth Factor Receptor 2 (HER2) Status(Assessed at baseline and after 24 weeks of treatment)
- Histopathological Response Rate (HRR)(Assessed at baseline and after 24 weeks of treatment)
- Progesterone Receptor (PgR) Status(Assessed at baseline and after 24 weeks of treatment)
- Anastrozole Plasma Concentrations (Cmin)(Assessed at week 12)
- Bone Turnover Marker (BAP) CLEIA Method(Assessed at baseline and after 24 weeks of treatment)
- Oestrogen Receptor (ER) Status(Assessed at baseline and after 24 weeks of treatment)
- Functional Assessment of Cancer Therapy-Breast (FACT-B)(Assessed at baseline and after 24 weeks of treatment)
- Endocrine Subscale (ES)(Assessed at baseline and after 24 weeks of treatment)