A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Trastuzumab-MCC-DM1 (PRO132365) Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen
Inclusion Criteria:
- Histologically documented, incurable, locally advanced or metastatic breast cancer
- Evaluable or measurable HER2-positive disease
- History of progression during or within 60 days after treatment with any prior
trastuzumab-containing chemotherapy regimen for HER2-positive breast cancer
- Previous treatment with chemotherapy for MBC
Exclusion Criteria:
- History of significant cardiac disease, unstable angina, CHF, myocardial infarction,
or ventricular arrhythmia requiring medication
- History of Grade ≥ 3 hypersensitivity reaction to trastuzumab
- History of any toxicity to trastuzumab that resulted in trastuzumab being permanently
discontinued
- Symptomatic brain metastases or any radiation or surgery for brain metastases within
3 months of first study treatment
- Require supplemental oxygen for daily activities
- Grade ≥ 2 peripheral neuropathy
- Bisphosphonate therapy for symptomatic hypercalcemia
- Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy
for the treatment of breast cancer within 4 weeks of first study treatment
- Any experimental therapy within 4 weeks of first study treatment
- Any major surgical procedure within 4 weeks of first study treatment
- History of clinically symptomatic liver disease, including viral or other hepatitis,
current or history of alcoholism, or cirrhosis
- Pregnancy or lactation