A Phase IIIb, Multi-center, Open-label Study of RAD001 in Combination With EXemestane in Post-menopausal Women With EStrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
研究概览
简要总结
This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitors (NSAI) therapy in Novartis Oncology emergent growth market (EGM) countries.Data was presented by Asian countries vs Non-Asian countries to confirm no difference in safety and efficacy. Summary statistics were presented.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with metastatic, recurrent or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
- •Histological or cytological confirmation of hormone-receptor positive (HR+) breast cancer.
- •Disease refractory to non-steroidal aromatase inhibitors, defined as:
- •Recurrence while on, or within 12 months (365 days) of completion of adjuvant therapy with letrozole or anastrozole, or
- •Progression while on, or within one month (30 days) of completion of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer (ABC).
- •Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrolment.
- •Patients must have had:
- •At least one lesion that could have been accurately measured in at least one dimension
- •20 mm with conventional imaging techniques or ≥ 10 mm with spiral CT or MRI, or
- •Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.
- •Adequate bone marrow, coagulation, liver and renal function.
- •ECOG performance status ≤ 2.
排除标准
- •Patients overexpressing HER2 by local laboratory testing (IHC 3+ staining or in situ hybridization positive). Patients with IHC 2+ must have a negative in situ hybridization test.
- •Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites).
- •Patients with more than one prior chemotherapy line for ABC. A chemotherapy line is an anticancer regimen(s) that contained at least 1 cytotoxic chemotherapy agent, given for a minimum of 21 days.
- •Previous treatment with mTOR inhibitors.
- •Known hypersensitivity to mTOR inhibitors, e.g. Sirolimus (rapamycin).
- •Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline was not required.
- •Patient who were being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
- •History of brain or other CNS metastases, including leptomeningeal metastasis.
研究组 & 干预措施
everolimus + exemestane
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily
干预措施: everolimus (Drug)
everolimus + exemestane
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily
干预措施: exemestane (Drug)
结局指标
主要结局
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
时间窗: Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries including a 30 day post treatment follow up period
Adverse events (AEs), serious adverse events (SAEs), changes from baseline in vital signs and laboratory results (hematology, blood chemistry, lipid profile) qualifying and reported as AEs. Although a patient might had two or more adverse events the patient is only counted once in a category. The same patient might appear in different categories. AESI: Adverse events of special interest.
次要结局
- Percentage of Participants Clinical Benefit Rate(Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries)
- Percentage of Participants Response Rates (Best Overall and Overall)(Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries)
- Progression Free Survival (PFS)(Baseline up to approximately 43 weeks for Asian countires and 40 weeks for Non-Asian countries)
- Percent of Participants Event-free Probability Estimates of Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status(Baseline up to approximately 50 weeks)