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.

MacroGenics, Inc.0 个研究点目标入组 530 人开始时间: 2015年9月4日最近更新: 2016年6月13日

适应症

试验速览

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•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

•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.

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