Phase
Condition
Bone Diseases
Bone Neoplasm
Hematologic Neoplasms
Treatment
Trastuzumab Emtansine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must have met applicable eligibility criteria in the Master MATCH Protocolprior to registration to treatment subprotocol
Patients' tumor sample must have HER2 amplification > 7 based on targeted customAmpliseq panel on the Ion Torrent Personal Genome Machine (PGM)
Hemoglobin >= 9.0 g/dL (which may be reached by transfusion)
Patients will be allowed if on anticoagulation (except warfarin and other coumarinderivatives) or on aspirin 81 mg by mouth daily. Additional monitoring while onanticoagulation will be based on institutional guidelines and/or physiciandiscretion. However, patients will not be allowed if on long acting anti-plateletagents such as clopidogrel
Patients must have an electrocardiogram (ECG) within 4 weeks prior to treatmentassignment and must have no clinically important abnormalities in rhythm, conductionor morphology of resting ECG (e.g. complete left bundle branch block, third degreeheart block)
Patients must have echocardiography (ECHO) or nuclear study (multigated acquisitionscan [MUGA] or First Pass) within 4 weeks prior to registration to treatment andmust not have a left ventricular ejection fraction (LVEF) < 50% to be eligible
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, forthe duration of study participation, and for 7 months after completion of study
Exclusion
Exclusion Criteria:
Patients with a diagnosis of breast cancer or gastric/gastroesophageal junction (GEJ) cancer will be excluded
Patients must not have known hypersensitivity to ado-trastuzumab emtansine orcompounds of similar chemical or biologic composition
Patients with current peripheral neuropathy of grade 3 or greater (National CancerInstitute [NCI]-Common Toxicity Criteria [CTC], version 4.0) will be excluded
Neuropathy assessment and grade assignment will be based on history (location,duration, balance and gait, effect on activity of daily living [ADLs]) andphysical exam
Patient must not have had any of the prior therapies:
Food and Drug Administration (FDA) approved:
Trastuzumab
Pertuzumab
Ado-trastuzumab emtansine
Investigational:
Margetuximab
PF-05280014 (Pfizer, Trastuzumab Biosimilar)
CT-P6 (Celltrion, Trastuzumab Biosimilar)
ABP-980 (Amgen, Trastuzumab Biosimilar)
Study Design
Study Description
Connect with a study center
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania 19103
United StatesSite Not Available
ECOG-ACRIN Cancer Research Group
Philadelphia 4560349, Pennsylvania 6254927 19103
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.