PERTUZUMAB INJ,SOLN
Clinical Criteria Summary
Exclusion Criteria
- Known hypersensitivity to pertuzumab or any of its excipients (L-histidine acetate, sucrose, polysorbate 20)
- Baseline Left Ventricular Ejection Fraction < 55% (< 50% if metastatic disease)
- Uncontrolled HTN
- 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
- Tissue does not overexpress HER2 protein (defined as IHC 3+ or FISH amplification ratio > 2.0)
- Pregnancy
Inclusion Criteria (Indications & Treatment Regimens)
- Metastatic breast cancer: In combination with trastuzumab and chemotherapy for patients not previously treated with HER2-directed therapy or chemotherapy
- Neoadjuvant therapy for breast cancer: In combination with trastuzumab and chemotherapy for HER2-positive, locally advanced, inflammatory, or early-stage breast cancer with primary tumor diameter > 2 cm or node positive
- Adjuvant therapy for breast cancer: In combination with trastuzumab and chemotherapy for HER2-positive, early breast cancer at high risk of recurrence
- Metastatic colorectal cancer: In combination with trastuzumab for HER2-positive, KRAS wild-type, chemotherapy-refractory metastatic colorectal cancer
Additional Inclusion Criteria (General Clinical Requirements)
- Care provided by VA or VA Community Care oncology provider
- Goals of care and role of Palliative Care consult discussed and documented
- Eastern Cooperative Oncology Group Performance Status 0 – 2
Additional Inclusion Criteria (Pregnancy & Contraception Management)
- For patients who can become pregnant and patients with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment; use of effective contraception during therapy and for 7 months after last dose