CTRI/2011/06/001805已完成4 期
A Multi-Centre, Prospective, Open Label Study on Safety and Efficacy of Letrozole as Adjuvant Treatment of Post-menopausal Women with Hormone Receptor Positive Early Breast Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Mean change in serum estradiol levels from baseline.
研究概览
简要总结
This study is a Phase-IV, multi centre, prospective, open label study to evaluate safety and efficacy of Letrozole in women with hormone receptor positive early breast cancer patients. The primary objective of the study is to determine mean change in serum estradiol levels from baseline to 14 weeks. Total 35 subjects will be enrolled from 3 centers of xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 45.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- Female
入选标准
- •Note: There is no upper age limit for this study.
- •1.Subjects or Legally Acceptable Representative (LAR) willing to sign informed consent.
- •2.Post menopausal women with non-metastatic breast cancer whose tumors are estrogen-and/or progesterone-receptor positive (ER and/or PgR positive) and have undergone breast cancer surgery with negative surgical margins.
- •4.Postmenopausal state was defined by the following conditions, at least one of •Serum follicle stimulating hormone (FSH) greater than or equal to 30 mIU/mL and amenorrhea greater than or equal to 1 year.
- ••Bilateral oophorectomy (OR) •Women without menses for the last 5 years.
- •5.Adequate bone marrow function as shown by •White Blood Cells (WBC) greater than or equal to 3.5 x 109/L •Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 109/L •Platelets greater than or equal to 100,000/ml •Hemoglobin (Hb) greater than or equal to 9 g/dL 6.Adequate hepatic function as shown by •Aspartate Aminotransferase (AST) 7–35 U/L •Alanine Aminotransferase (ALT) 7–31 U/L •Gamma Glutamyl Transferase (GGT) 5–36 U/L 7.Cholesterol levels 3.6–5.2 mmol/L 8.Subjects who have undergone surgery of breast cancer and received chemotherapy and/or radiotherapy (subjects should be considered for screening who have completed a minimum of 4weeks after receiving chemotherapy and/or radiotherapy).
排除标准
- •1.Multifocal/Multicentric disease (cancer that starts in several different sites). 2.Subjects with bilateral breast tumours. 3.Subjects with in-situ lesions in the contra-lateral breast. 4.Evidence of inflammatory breast cancer or distant metastasis. 5.Any adjuvant therapy within 4 weeks of screening. 6.Had previous or concomitant other (non-breast cancer) malignant disease within the past 5 years, apart from adequately treated basal or squamous-cell carcinoma of the skin or in-situ carcinoma of the cervix. 7.Subjects who were given any investigational drugs within the past 30 days. 8.Subjects treated with any other drugs known to influence plasma estrogen levels. 9.Subject with a drug induced menopausal status [e.g., Luteinizing-Hormone-Releasing Hormone (LHRH) treatment]. 10.Subjects who have a history of any of the following conditions within 6 months prior to study enrolment: •Clinically significant myocardial infarction or severe/unstable angina pectoris. •New York Heart Association (NYHA) class III or IV congestive heart failure. •Clinically significant cerebrovascular accident, transient ischemic attack or pulmonary embolism.
- •clinically significant pulmonary disease (e.g., severe chronic obstructive pulmonary disease or asthma). 11.Subjects who had breast cancer chemoprevention with anti-estrogens. 12.Subjects on hormone replacement therapy/adjuvant therapy unless stopped at least 4 weeks before screening visit except for estradiol vaginal tablets, estradiol vaginal ring, and estrogen cream. 13.Known history of hypersensitivity reactions to letrozole or to one of the excipients. 14.Subjects with Child-Pugh grade C, serum creatinine greater than 2xUNL. 15.Subjects with gastrectomy, small bowel resection, malabsorption syndrome, and dysphagia.
结局指标
主要结局
Mean change in serum estradiol levels from baseline.
时间窗: From baseline (Day0) to Visit 3 (Day21), Visit 4 (Day42), Visit 5 (Day84) and Visit 6 (Day98)
次要结局
- 3.Clinically significant vital examination, lab investigations, or X-ray findings.(During study period of 14 weeks)
- 2.Incidence of drug related adverse events.(From baseline (Day0) to Visit 3 (Day21), Visit 4 (Day42), Visit 5 (Day84) and Visit 6 (Day98))
- 4.Assessment of safety will be performed according to the National Cancer Institute’s common terminology criteria for adverse events (NCICTCAE) (version 4.0).(During study period of 14 weeks)
- 1.Incidence of adverse events.(From baseline (Day0) to Visit 3 (Day21), Visit 4 (Day42), Visit 5 (Day84) and Visit 6 (Day98))
研究者
研究点 (4)
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