EUCTR2015-000380-13-IT进行中（未招募）1 期
A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received Two Prior Anti-HER2 Therapies and Require Systemic Treatment -
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 530
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female patients = 18 years of age.
- •2. Have histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer. Tumors may be estrogen receptor (ER)/progesterone receptor (PR) positive or negative.
- •3. Have received prior treatment with pertuzumab, trastuzumab, and ado-trastuzumab emtansine in the neoadjuvant, adjuvant, or metastatic setting. Prior radiotherapy and hormonal therapies are allowed.
- •4. Have received treatment for at least one, and no more than two, lines of therapy in the metastatic setting. Prior neo-adjuvant or adjuvant therapy that resulted in relapse within 6 months of completion of
- •therapy will be considered a line of treatment for metastatic disease.
- •Eligible patients must have progressed on or following, the most recent line of therapy.
- •5. Resolution of all chemotherapy or radiation-related toxicities to =Grade 1 (with exception of = Grade 2 alopecia, stable sensory neuropathy, or stable electrolyte disturbances that are managed by
- •supplementation).
- •6. Have life expectancy = 12 weeks.
- •7. Have acceptable laboratory parameters.
- •8. Female patients of childbearing potential must have negative pregnancy test. All subjects should practice effective contraception.
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
排除标准
- •1. Patients with known, untreated brain metastasis. Patients with signs or symptoms of brain metastasis must have a CT or MRI performed
- •within 4 weeks prior to randomization to specifically exclude the presence of radiographically-detectable brain metastases.
- •2. History of uncontrolled seizures.
- •3. History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation.
- •4. History of clinically significant cardiovascular disease.
- •5. Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.
- •6. Any condition that would be a contraindication to receiving trastuzumab as described in the approved local label or a condition that would prevent treatment with the physician's choice of chemotherapies.
研究者
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