A Study to Evaluate Subjects Treated With rhuMab 2C4 (Pertuzumab) in a Previous Genentech Phase II Cancer Study

Inclusion criteria

• Signed informed consent
• ECOG performance status of 0, 1, or 2
• Completion of treatment in a previous Genentech sponsored, Phase II cancer study with pertuzumab, either alone or with a combination agent, in which at least one dose of pertuzumab was received in the parent study
• Less than 3 months since last dose of pertuzumab on the parent study
• Use of an effective means of contraception for men or for women of childbearing potential
• Granulocyte count >= 1500/uL
• Platelet count >= 75,000/uL
• Hemoglobin >= 9 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbepoetin [Aranesp(R)] is permitted)
• Serum bilirubin less than or equal to the upper limit of normal (ULN) (unless due to Gilbert's disease)
• Alkaline phosphatase, AST, and ALT <= 2.5x ULN (<= 5x ULN for subjects with liver metastases; no alkaline phosphatase upper limit for subjects with bone metastases)
• Serum creatinine <= 1.5x ULN
• International normalized ratio (INR) < 1.5 and activated partial thromboplastin time (aPTT) < 1.5x ULN (except for subjects receiving warfarin)

Exclusion criteria

• Recent (within the last 3 months), current, or planned participation in a experimental drug study other than a Genentech-sponsored pertuzumab cancer study
• Any unresolved or irreversible NCI-CTC Grade 3 or 4 adverse event or clinically meaningful cardiac adverse event (any grade) that is pertuzumab-related and ongoing from the parent study
• Recent (within the last 3 months) or current treatment with HER pathway inhibitors other than pertuzumab (e.g., Herceptin(R) [Trastuzumab], Iressa<TM> [gefitinib], Tarceva<TM> [erlotinib hydrochloride], C225, CI1033, or TAK165) or other monoclonal antibodies
• Clinical evidence of central nervous system or brain metastases
• Ejection fraction ≤50%, as determined by ECHO (or MUGA)
• Uncontrolled hypercalcemia (> 11.5 mg/dL)
• Recent anthracycline exposure (within the last 3 months) or cumulative exposure of > 360 mg/m^2 doxorubicin or equivalent (i.e., liposomal doxorubicin, > 120 mg/m^2 mitoxantrone, or > 90 mg/m^2 idarubicin)
• Ongoing corticosteroid use (except for subjects who are on stable doses of < 20 mg of prednisone daily [or equivalent] or who are taking corticosteroids for reasons other than cancer)
• Other malignancies (except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, or basal or squamous cell skin cancer)
• Serious systemic disease, including active infection, uncontrolled hypertension (diastolic blood pressure > 100 mmHg on two consecutive occasions), unstable angina, congestive heart failure, or myocardial infarction or unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia [i.e., atrial fibrillation], paroxysmal supraventricular tachycardia, or controlled hypertension are eligible)
• Liver disease (including viral or other hepatitis), current alcohol abuse, or cirrhosis
• Known human immunodeficiency virus infection
• Pregnancy or lactation
• Major surgery or significant traumatic injury within 3 weeks prior to Day 1
• Inability to comply with study and follow-up procedures
• Any diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the continued use of an investigational drug or that may render the subject at high risk from treatment complications