ADO-TRASTUZUMAB INJ

Clinical Criteria Summary

Known hypersensitivity to ado-trastuzumab emtansine or its excipients (sodium succinate, sucrose, polysorbate 20)
Baseline Left Ventricular Ejection Fraction (LVEF) < 50%
Uncontrolled hypertension or arrhythmia requiring treatment
Myocardial infarction within prior 6 months
History of Congestive Heart Failure (New York Heart Association Class 3 or 4)
Cumulative prior anthracycline exposure > 360 mg/m2 of doxorubicin or its equivalent
Breast tissue does not overexpress HER2 protein (HER2 positive status defined as IHC 3+ or FISH amplification ratio > 2.0)
Platelet count < 100,000/ mm3
Grade 3 or higher peripheral neuropathy
Serum transaminases (ALT/AST) > 2.5x ULN and/or Total bilirubin > 1.5x ULN or active hepatitis B or C virus
Interstitial Lung Disease or pneumonitis

Metastatic setting: Patient received prior treatment for metastatic breast cancer that includes trastuzumab and taxane (separately or in combo) OR disease recurred during or within 6 months of completing adjuvant therapy
Adjuvant therapy: Patient with early breast cancer with residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment

Care for the condition provided by VA or VA Community Care oncology provider
Goals of care and role of Palliative Care consult have been discussed and documented
Eastern Cooperative Oncology Group Performance Status 0-2

Pregnancy must be excluded prior to receiving therapy for patients who can become pregnant
Counseling on potential risks vs benefits and use of effective contraception during therapy and for 7 months after stopping treatment for patients who can become pregnant
Counseling on potential risks vs benefits and use of effective contraception during therapy and for 4 months after stopping treatment for patients with partners who can become pregnant

Clinically significant cardiovascular disease (baseline Left Ventricular Ejection Fraction < 55% via MUGA or echocardiography; <50% if metastatic disease; uncontrolled hypertension or arrhythmia; myocardial infarction within prior 6 months; CHF NYHA Class 3 or 4)
Cumulative prior anthracycline exposure > 360 mg/m2 of doxorubicin or its equivalent
Interstitial lung disease or pneumonitis
Pregnancy
Lactating
Primary Inclusion Criteria (One must be fulfilled)
HER2-overexpressing (IHC 3+ or FISH amplification ratio > 2.0) breast cancer
HER2-overexpressing gastric or gastroesophageal junction adenocarcinoma
Additional Clinical & Administrative Inclusion Criteria (All must be fulfilled)
Care provided by VA or VA Community Care provider of oncology
Goals of care and role of Palliative Care consult discussed and documented, if appropriate
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Reproductive Health & Contraception Requirements (Select if applicable)
For females who can become pregnant: Pregnancy must be excluded prior to receiving therapy
For females who can become pregnant: Counseling provided on potential risks vs. benefits of treatment and use of effective contraception during therapy and for 7 months after the last dose