An open-label, phase II, single-arm study of everolimus in combination with letrozole in the treatment of postmenopausal women with estrogen receptor positive HER2 negative metastatic or locally advanced breast cancer

ovartis Pharma Services AG0 个研究点目标入组 200 人开始时间: 2013年2月25日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•Patients 18 years old or greater
•Patients with metastatic or locally advanced, unresectable breast cancer not amenable to curative treatment by surgery or radiotherapy
•Histological or cytological confirmation of estrogen-receptor positive (ER+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer
•Postmenopausal women
•No prior treatment for metastatic breast cancer
•Other protocol based inclusion criteria may apply
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 108
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 94

•Patients with only non-measurable lesions other than bone metastases (e.g., pleural effusion, ascites, etc)
•Patients who have received prior hormonal or any other systemic therapy for metastatic breast cancer.
•Patients may have received prior neoadjuvant or adjuvant endocrine therapy. In the case of neoadjuvant or adjuvant NSAI (letrozole/anastrozole) therapy patients must have completed therapy at least 1 year prior to study enrollment.
•Previous treatment with mTOR inhibitors.
•Known hypersensitivity to mTOR inhibitors, e.g., sirolimus (rapamycin).
•Other protocol-defined inclusion/exclusion criteria may apply
•Other protocol based exclusion criteria may apply

发起方