Pertuzumab and Trastuzumab in Treating Patients with HER2 Positive Breast Cancer with Untreated Brain Metastasis

Inclusion Criteria

• HER2 positive by 2013 American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines (immunohistochemistry [IHC] 3+ and/or fluorescence in situ hybridization [FISH] positive; IHC 2+ HER2 patients are eligible with reflex FISH positive testing with the ratio >= 2.0) breast cancer patients with untreated asymptomatic or minimally symptomatic brain metastasis by MRI; there is no upper or lower limit to the size or number of brain metastases
• Patients can have previous brain metastasis that was completely surgically resected if the previously resected lesion is at least 1 cm from target lesion(s) for this study; the location of the previous resection cavity is determined by the post-resection MRI
• Patients can have previous brain metastasis that was treated with stereotactic radiosurgery (SRS) if the previously treated lesion is at least 1 cm from the target lesion(s) for this study; the location of the previous SRS treatment location is determined by the SRS MRI
• Patients can be on steroids as long as the dose has been stable for >= 7 days
• No limitations on prior systemic or intrathecal therapies
• There are no restrictions on systemic therapy at enrollment
• Negative serum pregnancy test for pre-menopausal women and women within 12 months from the onset of menopause
• Sexually active women of childbearing potential must commit to 2 methods of contraception while enrolled on the trial and continue using contraceptives for at least 7 months post study drug administration; sexually active men must commit to 1 method of contraception while enrolled and for 7 months after; hormonal contraceptives such as birth control pills, patches, implants or injections are not allowed in patients who are hormone receptor (HR) positive (+)
• Life expectancy >= 8 weeks
• Creatinine < 1.5 x upper limit of normal (ULN)
• Bilirubin =< 1.5 x ULN
• Transaminases =< 2 x ULN, except in known hepatic disease, wherein may be =< 5 x ULN
• White blood cells (WBC) >= 2.0
• Neutrophils >= 1,500
• Platelets >= 100,000
• Hemoglobin >= 10
• LVEF (left ventricular ejection fraction) >= 50%
• Karnofsky performance status (KPS) >= 50
• Patients must have the ability to give informed consent
• Patients must sign an informed consent form

Exclusion Criteria

• No seizures, focal weakness of any extremity (by neurologic exam), or stroke symptoms in the past month
• No history of prior whole brain radiation
• No history of lumbar surgery or other pre-existing spinal conditions that would preclude frequent, safe, reliable lumbar punctures
• No history of serious cardiac arrhythmia or ejection fraction (EF) < 50%
• Systemic sites of disease need to be stable on systemic therapy based on the most recent (within 12 weeks) staging scans
• Radiation while on study is not allowed EXCEPT to a localized region for pain control
• No history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless the patient has been in remission and off all other cancer therapy for at least 3 years
• Patients should have no significant psychiatric illness or medical illness that would preclude the ability to comply with the protocol
• Patients may not be pregnant or breastfeeding
• No known hypersensitivity to trastuzumab or pertuzumab
• Symptomatic intrinsic lung disease or extensive tumor involvement in the lungs resulting in dyspnea at rest