NCT00330317已完成3 期
Neoadjuvant Hormone Therapy for Postmenopausal Women With HR+ Primary Breast Cancer: A Multi-center Study to Determine the Optimum Length of Treatment With Letrozole on Tumour Regression to Permit Breast Conserving Surgery.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Optimum length of treatment with letrozole (2.5 mg daily) preoperatively, on tumour measured by clinical examination and breast ultrasound
研究概览
简要总结
The aim of this study is to assess the safety and efficacy of neoadjuvant hormone therapy with letrozole in postmenopausal women with estrogen- and/or progesterone-receptor positive primary breast cancer on tumour regression to permit breast conserving surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women able to comply with the protocol requirements with confirmed primary invasive breast cancer whose tumours are estrogen-and/or progesterone-receptor positive
- •Clinical stage T2 or >T2 tumours which in the investigators' opinion would not be eligible for breast-conserving surgery. The nodal status will be evaluated by palpation and/or ultrasound.
- •Postmenopausal status defined by one of the following:
- •Women with an intact uterus AND
- •≥ 55 years of age, OR
- •< 55 years of age without menses for the last 5 years, OR
- •< 55 years of age and have not had menses for at least the last 12 months (but have had menses in the last 5 years) and have postmenopausal levels of follicle-stimulating hormone.
- •Women without an intact uterus AND
- •≥ 55 years of age, OR
- •< 55 years of age and postmenopausal levels of follicle-stimulating hormone
- •Both ovaries removed (prior to the diagnosis of breast cancer).
- •Tumour measurable by clinical examination, mammography and ultrasound
- •Adequate bone marrow function as shown by:
- •WBC ≥ 3.5 x 10^9/L
- •ANC ≥ 1.5 x 10^9/L
- •Platelets ≥ LLN
- •Hb > 10 g/dL
排除标准
- •Multifocal disease (cancer that starts in several different sites)
- •Patients with bilateral breast tumours.
- •Patients who are eligible for breast conserving surgery.
- •Evidence of inflammatory breast cancer or distant metastasis.
- •Simultaneous anti-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers, endocrine therapy (including steroids), bisphosphonate therapy and radiotherapy. NOTE: Bisphosphonate therapy for osteoporosis is NOT excluded, and can be continued. Patients who have received hormone replacement therapy will NOT be excluded if it is discontinued at least 2 weeks before starting the study.
- •The following additional treatments are NOT allowed during the treatment phase of the study:
- •Any other anti-cancer therapy
- •Hormone replacement therapy.
- •Estrogen cream (including any intra-vaginal preparation).
- •Steroids other than creams or inhalers.
- •Megestrol acetate for the treatment of hot flushes.
- •Radiation therapy.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Letrozole
Experimental
干预措施: letrozole (Drug)
结局指标
主要结局
Optimum length of treatment with letrozole (2.5 mg daily) preoperatively, on tumour measured by clinical examination and breast ultrasound
时间窗: 12 months
次要结局
- Long term (5-year) local recurrence rate(5 years)
- Response rate in line with the Response Evaluation Criteria in Solid Tumors criteria(12 months)
- Safety and tolerability of the treatment prior to surgery(5 years)
- Reduction in tumour volume every 2 months throughout the study(12 months)
研究者
研究点 (1)
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eoadjuvant hormone therapy for postmenopausal women with ER and/or PgR positive primary breast cancer: A multi-center study to determine the optimum length of treatment with Femara (letrozole 2.5mg daily) on tumour regression to permit breast conserving surgery.Postmenopausal women with ER and/or PgR positive primary breast cancerEUCTR2005-000661-19-GBovartis Pharmaceuticals UK Ltd
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