CTRI/2011/05/001733已完成4 期
A Phase IV, Single Arm, Open label, Multi-Centric Study to Evaluate Efficacy, Safety and Tolerability of Anastrozole as an adjuvant to Paclitaxel for Postmenopausal Women with hormone-receptor positive metastatic Breast Cancer .
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Percentage reduction in the Serum Estradiol levels as compared to baseline in Hormone-receptor Positive Metastatic Breast Cancer patients
研究概览
简要总结
This study is a single arm, open label, multi-centric study to evaluate efficacy, safety and tolerability of Anastrozole as an adjuvant to Paclitaxel for postmenopausal women with hormone-receptor positive metastatic breast cancer. In this study 30 subjects will be enrolled from 4 participating centers in India.The primary objective of study is to measure and compare the effects of Anastrozole in the reduction of serum estradiol levels in metastatic breast cancer patients. Study will be conducted in 2 phases: Screening Phase (Screening Visit) and Enrollment & Treatment Phase (Visit 1 – Visit 7). The study duration is of 32 weeks including 2 weeks of screening, 12 weeks of enrolment period, and 18 weeks of treatment period.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
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 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Note: This trial do not have upper age limit for inclusion criteria.
- •1.A potential subject willing to give written informed consent on his own or legally acceptable representative (LAR) /Impartial witness in case of Illiterate subject and comply with all study procedures.
- •2.Female subjects entering the study should be greater than or equal to 45 Years of age.
- •3.Subjects entering the study should be Post-menopausal women, defined as: a.Bilateral Surgical Oophorectomy or Amenorrhea greater than or equal to 5 years b.Age greater than or equal to 45 years and Amenorrhea greater than or equal to 1 year c.Chemotherapy induced Amenorrhea greater than or equal to 2 years d.Radiotherapy induced Amenorrhea at least 3 months before.
- •4.Subjects participating in the study should be those with histologically or cytologically proven pathological diagnosis of Metastatic Breast Cancer 5.Subjects should have been proven Estrogen Receptor and/or Progesterone Receptor Positive (ER+/PR+).
- •6.Subjects entering the study should have a radiologically measurable disease 7.Subjects who have received adjuvant Tamoxifen are eligible, if progression has been established within 24 months since treatment start.
- •8.Subjects receiving Paclitaxel as first line of chemotherapy for advanced Metastatic Breast Cancer or Treatment-naive patients.
- •9.Subjects who have received previous treatment with targeted therapy are eligible, whereas subjects already receiving Anastrozole or other aromatase inhibitors should undergo a one month washout period prior to the start of study drug administration.
- •10.Subjects entering the study should have following Normal Hematological values (Hb greater than 9.0 gm/ dL, Platelet greater than or equal to 1, 00000/ cumm), Hepatic Profile (Bilurubin, Total Biluribin less than or equal to 1.5 times ULN, Alalnine Transaminase (ALT)less than or equal to 2.5 time ULN, Aspartate Transaminase (AST) less than or equal to 2.5 times ULN, Alkaline Phosphatase (ALP) less than 2.5 ULN,)) and Renal Functions (Serum Creatinine less than or equal to 1.5 times ULN).
- •11.Subjects entering the study should have an ECOG Performance Status of 0-
- •12.Subjects participating in the study should have a life expectancy of at least 6 months, or as per the investigators discretion.
排除标准
- •Note: This trial do not have upper age limit for exclusion criteria.
- •Subjects who are pre-menopausal women.
- •2.Subjects who have received previous hormone treatment with class of aromatase inhibitor or any other hormonal treatment within 1 month in metastatic disease.
- •3.Subjects who are negative for Estrogen Receptor and/or Progesterone Receptor (Negative ER- / PR status).
- •4.Subjects receiving Glucocorticoid therapy 5.Subjects with an increase in High Density Lipoprotein-Cholesterol (HDL-C).
- •6.Subjects with known Inflammatory breast cancer, refractory malignancy or metastasis in the central nervous system 7.Subjects with only bone metastasis.
- •8.Subjects with a non-measurable disease.
- •9.Subjects with known hypersensitivity to the study drug or to any of the excipients.
- •10.Subjects with secondary malignancy except for basal skin carcinoma or adequately treated cervical in-situ carcinoma 11.Subjects who have participated in any other investigational drug therapy within 1 month prior to the screening visit.
- •12.Subjects with any other severe concurrent disease, which in the judgment of the investigator would make the subject inappropriate for entry into this study.
结局指标
主要结局
Percentage reduction in the Serum Estradiol levels as compared to baseline in Hormone-receptor Positive Metastatic Breast Cancer patients
时间窗: At Visit-2 (Day 21) and Visit-7 (Day 126)
次要结局
- Percentage of subjects who achieve complete or partial response and assessed for overall response as per RECIST Version 1.1 using imaging studies (CT/ MRI)(At Visit 4 (Day 63) and Visit 7 (Day 126).)
- Percentage of subjects who achieve Time to progression (TTP) as per RECIST Version 1.1 using imaging studies (CT/ MRI)(At Visit 4 (Day 63) and Visit 7 (Day 126).)
- Percentage of subjects who achieve Progression Free Survival (PFS) as per RECIST Version 1.1 using imaging studies (CT/ MRI)(At Visit 4 (Day 63) and Visit 7 (Day 126).)
- Treatment Emergent Adverse Events (TEAE defined as an AE which is definitely or probably related to study medication) as per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.02.(During study period.)
- Safety of the study drug will be estimated from type, number, frequency and percentage of subjects with AE(s)(During study period.)
研究者
研究点 (5)
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