EUCTR2011-000198-29-DE
进行中（未招募）
1 期
A Phase 1b/2 Randomized Study of MEDI-573 in Combination with an Aromatase Inhibitor (AI) Versus AI Alone in Women with Metastatic Breast Cancer (MBC)
适应症Advanced Metastatic Breast Cancer (MBC)MedDRA version: 18.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10006202Term: Breast cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Advanced Metastatic Breast Cancer (MBC)
- 发起方
- MedImmune, LLC
- 入组人数
- 178
- 状态
- 进行中（未招募）
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Histologically\-confirmed MBC not deemed amenable to curative surgery or curative radiation therapy
- •(subjects with bone metastases are eligible but enrollment will be capped at approximately 30 subjects)
- •Tumors are positive for ER, PgR, or both
- •Tumors must be negative for HER2 (by FISH or CISH or ICH)
- •Female gender and age \= 18 years at time of study entry
- •Postmenopausal
- •Karnofsky Performance Status \= 70
- •Life expectancy of \= 6 months
- •Adequate organ and marrow function
- •Suitable candidate for AI therapy
排除标准
- •Subjects who received prior chemotherapy, hormonal therapy,
- •immunotherapy or biologic therapy for advanced or metastatic disease with the following exceptions:
- •Prior adjuvant therapy with an AI and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of MEDI\-573 Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed
- •Extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or disease that is considered by the investigator to be rapidly progressing or life threatening (eg, subjects who are intended for chemotherapy) Active brain metastases with the exception of subject has been treated and are asymptomatic and there has been no evidence of CNS progression for at least 4 weeks of first dose of MEDI\-573 Evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis
- •Unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to \= Grade 1 at the time of starting study treatment
- •Receipt of any investigational therapy within 30 days or 5 half\-lives,
- •prior to recieving study treatment
- •Previous treatment with agents that target the IGF receptor
- •History of allergy or reaction attributed to compounds of chemical or biologic composition similar to those of MEDI\-573 or AI
- •Use of immunosuppresive med other than steroids within 7d before 1st dose of study drug
结局指标
主要结局
未指定
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