A PROSPECTIVE PRAGMATIC CLINICAL TRIAL OF CHINA EARLY INVASIVE BREAST CANCER PATIENTS RECEIVING ADJUVANT THERAPY WITH AROMASIN
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 564
- 试验地点
- 53
- 主要终点
- Time-to-Event
研究概览
简要总结
Aromasin® (Exemestane) was approved in China for adjuvant treatment of postmenopausal women with estrogen receptor (ER) positive early invasive breast cancer who have received 2-3 years of tamoxifen & are switched to Aromasin® for completion of a total of 5 consecutive years of adjuvant hormonal therapy by State Food and Drug Administration (SFDA) with clinical trial waive. While Aromasin® has been used in China for adjuvant therapy of breast cancer since then, there is currently lack of systematic collection and analysis for the efficacy and safety data of Aromasin® adjuvant setting in Chinese population. The Aromasin® Interventional Study is being proposed to collect data systematically and to assess the efficacy and safety of Aromasin® adjuvant setting in Chinese population.
详细描述
This is interventional study and single arm study. N/A
研究设计
- 研究类型
- Interventional
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Early invasive breast cancer (T1-4N1-3M0) confirmed by histology or cytology.
- •ER positive.
- •The patient must be postmenopausal woman.
- •The patient has received adjuvant Tamoxifen therapy for up to 2-3 years and will switch to receive Aromasin® treatment (The decision to prescribe Aromasin® will necessarily precede and will be independent of the decision to enroll patients in the study).
排除标准
- •Following the adjuvant Tamoxifen therapy for 2-3 years and prior to receiving Aromasin® treatment, there is evidence of a local relapse or distant metastasis of breast cancer, or a second primary cancer.
- •Following the adjuvant Tamoxifen therapy for 2-3 years and received other aromatase inhibitors (not Aromasin®).
研究组 & 干预措施
A
干预措施: Aromasin (exemestane) (Drug)
结局指标
主要结局
Time-to-Event
时间窗: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)
An event was defined as the earliest occurrence of any of the following: 1) Loco-regional/distant recurrence of the primary breast cancer (BC) (Loco-regional recurrence was defined as any recurrence in the ipsilateral breast, chest wall or axillary lymph nodes.); 2) Appearance of a second primary or contralateral breast cancer; 3) Death due to any cause.
次要结局
- Incidence Rate of Each Event(2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years))
- Percentage of Participants Experiencing Each Event(2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years))
- Harzard Ratio: the Relationship Between Multiple Disease Variables and Time-to-Event(2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years))
- Number of Participants With Discontinuation Due to Adverse Events (AEs)(2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years))
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years))
- Hazard Ratio: the Relationship Between (Human Epidermal Growth Factor Receptor 2) HER2 Status and Time-to-Event(2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years))