Investigation of the clinical effects of combination therapy using LH-RH analogue + Anastrozole on patients with hormone receptor positive, premenopausal advanced/recurrent breast cancer resistant to combination therapy using LH-RH analogue + Tamoxifen - JMTO BC08-01
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
ONCOLOGY REPORT Vol: 29 No: 5 1707-1713 (May 2013). Title: Efficacy of goserelin plus anastrozole in premenopausal women with advanced or recurrent breast cancer refractory to an LH-RH analogue with tamoxifen: Results of the JMTO BC08-01 phase II trial. Results: Between September 2008 and November 2010, 37 patients were enrolled. Thirty-five patients (94.6%) had ER-positive tumors, and 36 (97.3%) had human epidermal growth factor receptor (HER) 2-negative tumors. Thirty-six (97.3%) had measurable lesions and 1 (2.7%) had only bone metastasis. The ORR was 18.9% [95% confidence interval (CI), 8.0-35.2%], the CBR was 62.2% (95% CI, 44.8-77.5%) and the median PFS was 7.3 months. Eight patients had adverse drug reactions but none resulted in discontinuation of treatment. GOS plus ANA is a safe effective treatment for premenopausal women with hormone receptor-positive, recurrent or advanced breast cancer. The treatment may become viable treatment in the future, particularly when TAM is ineffective or contraindicated. Further studies and discussion are warranted.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 55years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •Patients falling under any of the following 1.Patients with a history of drug allergy against the test drug and co-administered drug 2.Patients administered another anticancer drug since the prior treatment [LH-RHa + TAM therapy or LH-RHa + TAM followed by TAM therapy] 3.Patients receiving ongoing systemic administration [orally or intravenously] of an adrenal cortex hormone 4.Patients with advanced cancer in another organ less than 5 years after the completion of treatment 5.Patients with a history of thrombotic disease such as deep vein thrombosis or cerebral infarction 6.Patients with a history of severe heart disease such as myocardial infarction, valvular heart disease or heart failure 7.Patients receiving administration of HRT for treatment of menopausal symptoms within 4 weeks of registration 8.Women who are pregnant, lactating or may be [intend to be] pregnant 9.Patients planning treatment with an anticancer drug other than LH-RHa + Anastrozole, a bisphosphonate or radiation therapy on a target lesion following the start of this trial 10.Other cases who the doctor responsible for the trial judges unsuitable