NL-OMON41506已完成2 期
An open-label, phase II, single-arm study of everolimus in combination with letrozole in the treatment of postmenopausal women with estrogen receptor positive metastatic breast cancer (CRAD001Y24135) - CRAD001Y24135 (Bolero-4)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Postmenopausal (>= 18 years) women with locally advanced or metastatic breast cancer not amenable to curative treatment. Postmenopausal status definition: see protocol page 27 for details
- •No prior treatment for metastatic breast cancer.
- •Must have measurable disease (see protocol page 27) or non-measurable lytic or mixed (lytic + sclerotic) bone lesions.
- •ECOG performance status 0-2.
排除标准
- •Prior hormonal or any other systemic therapy for metastatic breast cancer. Prior 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.
- •HRT unless discontinued prior to enrollment.
- •Evidence of CNS metastases.
- •Chronic treatment with systemic immunosuppressive agents.
- •Bilateral diffuse lymphangitic carcinomatosis.
研究者
相似试验
进行中（未招募）
1 期
Study of efficacy and safety of everolimus and letrozole in estrogen receptor positive HER2 negative metastatic or locally advanced breast cancer patientsEstrogen receptor positive metastatic breast cancerMedDRA version: 20.0 Level: PT Classification code 10070577 Term: Oestrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-003065-17-GBovartis Pharma Services AG200
进行中（未招募）
1 期
A clinical study of everolimus in combination with letrozole in the treatment of postmenopausal women with estrogen receptor positive metastatic breast cancerEstrogen receptor positive metastatic breast cancerMedDRA version: 19.0Level: PTClassification code 10070577Term: Oestrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-003065-17-NLovartis Pharma Services AG158
进行中（未招募）
1 期
Study of efficacy and safety of everolimus and letrozole in estrogen receptor positive HER2 negative metastatic or locally advanced breast cancer patients.EUCTR2012-003065-17-PTovartis Pharma Services AG202
进行中（未招募）
1 期
Study of efficacy and safety of everolimus and letrozole in estrogen receptor positive HER2 negative metastatic or locally advanced breast cancer patients.EUCTR2012-003065-17-HUovartis Pharma Services AG200
进行中（未招募）
1 期
A clinical study of everolimus in combination with letrozole in the treatment of postmenopausal women with estrogen receptor positive metastatic breast cancerEUCTR2012-003065-17-ESovartis Farmacéutica S.A.202