Ado-trastuzumab Emtansine in Patients with Tumors with HER2 Amplification (Except Breast and Gastric/Gastro-Esophageal Junction (GEJ) Adenocarcinomas) (MATCH Substudy)
This phase II MATCH treatment trial identifies the effects of ado-trastuzumab emtansine in patients whose cancer has a genetic change called HER2 amplification. Ado-trastuzumab emtansine is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called DM1. Trastuzumab is a form of "targeted therapy", because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors and delivers DM1 to kill them. Researchers hope to learn if the study drug will shrink this type of cancer or stop its growth.
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Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol;
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Patients' tumor sample must have HER2 amplification > 7 based on targeted custom Ampliseq panel on the Ion Torrent Personal Genome Machine (PGM);
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Hemoglobin >= 9.0 g/dL (which may be reached by transfusion);
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Patients will be allowed if on anticoagulation (except warfarin and other coumarin derivatives) or on aspirin 81 mg by mouth daily. Additional monitoring while on anticoagulation will be based on institutional guidelines and/or physician discretion. However, patients will not be allowed if on long acting anti-platelet agents such as clopidogrel;
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Patients must have an electrocardiogram (ECG) within 4 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)
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Patients with a diagnosis of breast cancer or gastric/gastroesophageal junction (GEJ) cancer will be excluded;
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Patients must not have known hypersensitivity to ado-trastuzumab emtansine or compounds of similar chemical or biologic composition;
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Patients with current peripheral neuropathy of grade 3 or greater (National Cancer Institute [NCI]-Common Toxicity Criteria [CTC], version 4.0) will be excluded
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Neuropathy assessment and grade assignment will be based on history (location, duration, balance and gait, effect on activity of daily living [ADLs]) and physical exam;
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Patient must not have had any of the prior therapies:
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Food and Drug Administration (FDA) approved:
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Trastuzumab
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Pertuzumab
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Ado-trastuzumab emtansine
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Investigational:
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Margetuximab
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PF-05280014 (Pfizer, Trastuzumab Biosimilar)
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CT-P6 (Celltrion, Trastuzumab Biosimilar)
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ABP-980 (Amgen, Trastuzumab Biosimilar)
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