TRASTUZUMAB-DKST INJ

Exclusion Criteria

• 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