Phase II Randomized, Multicenter, Crossover Clinical Trial for Administration of Exemestane vs. Anastrozole as First Line Treatment for Postmenopausal Patients With Hormone Receptor Positive Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 13
- 主要终点
- Overall Response Rate (ORR) in both arms
研究概览
简要总结
This is a pivotal phase II, multicenter, open-label trial, designed to compare the efficacy of exemestane versus anastrozole as a first line treatment for advanced breast cancer. One hundred postmenopausal patients, with metastatic, positive hormone receptor breast cancer will be enrolled in this trial.
详细描述
The primary study endpoint is objective response rate. The study has been designed following Simon's test, with a p1-p0=0.15. p1 is the optimum level of activity of the experimental treatment (exemestane), and p0 is the minimum expected activity. In this study, p1 is 25% (25% of RR) and p0 is 10% (10% of RR). With an alpha error of 0.05 and a beta error of 0.1, Simon test establishes a first step of 21 patients per treatment arm. If at least 2 objective responses are observed in exemestane arm, recruitment will continue until 100 patients have been recruited. After this second recruitment phase, at least 7 objective responses must be observed to confirm the expected exemestane level of activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnoses of breast cancer.
- •Postmenopausal women, defined as:
- •Bilateral surgical oophorectomy or amenorrhoea >= 5 years;
- •Age >= 56 years old and amenorrhoea >= 1 year;
- •Chemotherapy induced amenorrhoea >= 2 years;
- •Radiotherapy induced amenorrhoea at least 3 months before:
- •Age < 56 and < 5 years of amenorrhoea: follicle-stimulating hormone (FSH) levels to confirm postmenopausal status.
- •Metastatic breast cancer (stage IV) or non-operable locally advanced breast cancer (stage IIIB).
- •Positive estrogen and/or progesterone receptors as >10% cells or >10fmol/mg.
- •Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •Patients who have received adjuvant tamoxifen are eligible, if progression has been established at least 24 months since treatment start.
- •Neoadjuvant chemotherapy is allowed if progression has been established at least 12 months after end of treatment.
- •Patients may have received a first line of chemotherapy for advanced disease, but treatment must have ended at least 4 weeks before enrolment, and all acute toxicities must be resolved. Previous treatment with Herceptin is allowed.
- •Normal haematological, hepatic and renal functions.
- •Performance status ECOG of 0, 1,
- •Life expectancy superior to 3 months.
- •Written informed consent.
排除标准
- •Previous hormone treatment for metastatic disease.
- •Previous treatment with aromatase inhibitors.
- •Inflammatory breast cancer, or aggressive metastatic disease, or visceral lesions, or metastasis in the central nervous system (CNS).
- •Non-measurable disease.
- •Second malignancy except for basal skin carcinoma or cervical in situ carcinoma adequately treated. If other malignancies, patient must have a disease-free period superior to 5 years.
- •Treatment with any investigational product in the 4 previous weeks.
- •Patients with negative estrogen and progesterone receptor tumours.
研究组 & 干预措施
Exemestane
25mg/day per VO until progression disease, after this progression the patient could receive the another drug (comparator arm) ie Anastrozole by investigator decision
干预措施: Anastrozole (Drug)
Anastrozole
1mg/day per VO until progression disease, after this progression the patient could receive the another drug (experimental arm) ie Exemestane by investigator decision
干预措施: Exemestane (Drug)
结局指标
主要结局
Overall Response Rate (ORR) in both arms
时间窗: up to 12 months
Complete response plus partial response
次要结局
- Time to progression after crossover(From date of crossover until the date of new documented progression, assessed up to 5 months)
- Survival(up to 36 months)
- Survival after crossover(up to 24 months)
- Time to progression(From date of randomization until the date of new documented progression, assessed up to 24 months)
- The Number of Participants Who Experienced Adverse Events (AE)(Until 30 days after the end of last patient study treatment (1st line))
- Clinical benefit (1st line)(up to 6 months)
- Toxicity after crossover(Until 30 days after the end of last patient study treatment (crossover: 2nd line))
- Clinical benefit after crossover (2nd line)(up to 6 months)