Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Puma Biotechnology, Inc.
Arm A: HER2 gene amplification and disease progression following at least 6 weeks of standard doses of Herceptin; Arm B: HER2 gene amplification and no prior Herceptin or HER2-targeted treatment.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV
Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)
Over-expression of HER2
Tumor tissue available and adequate for analysis at screening
At least one measurable lesion
You may not be if
Prior treatment with Herceptin (Arm B only)
More than 4 prior cytotoxic chemotherapy regimens
Subjects with bone or skin as the only site of measurable disease
Inadequate cardiac function
Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1
