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临床试验/NCT00605267
NCT00605267已完成3 期

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

AstraZeneca1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Tamoxifen

干预措施: Tamoxifen (Drug)

1

Active Comparator

Tamoxifen

干预措施: Goserelin acetate (Zoladex) (Drug)

2

Experimental

Anastrazole (Arimidex)

干预措施: Anastrazole (Arimidex) (Drug)

2

Experimental

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)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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