An Open-label, Dose-finding Study to Evaluate the Safety of AMG 706 in Combination With Paclitaxel or Docetaxel as Treatment for Locally Recurrent or Metastatic Breast Cancer
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally
recurrent or metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Female 18 years of age or older.
- Adequate hematologic, renal and hepatic function.
- Competent to comprehend, sign, and date an IRB-approved informed consent form.
- Subjects of childbearing potential and sexually active must provide a negative
pregnancy test and use accepted and effective method of contraception.
- Prior taxane-containing treatment within 6 months prior to enrollment.
- Prior treatment including chemotherapy and/or endocrine therapy discontinued < 21
days prior to enrollment.
- More than one prior systemic chemotherapy for locally recurrent or metastatic breast
- Current or prior history of central nervous system metastases.
- History of arterial or venous thrombosis within 1 year prior to enrollment.
- History of bleeding diathesis or bleeding within 14 days prior to enrollment.
- Radiation therapy to a significant portion of bone marrow or prior history of
high-dose chemotherapy requiring bone marrow or stem cell support.
- Hypersensitivity to paclitaxel, docetaxel, or drugs using the vehicle cremophor.
- Prior VEGFr targeted therapies within 30 days of enrollment.
- Any anticoagulant therapy within 7 days prior to enrollment, except for warfarin of
less than 2mg per day.
- Clinically significant cardiac disease including myocardial infarction or other
cardiovascular related event within 1 year before enrollment.
- Uncontrolled hypertension (systolic >150 mmHg; diastolic > 90 mmHg).
- Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive.
- Prior bevacizumab or trastuzumab therapy within 12 weeks of enrollment.
- Non-healing wound, ulcer or fracture.
- Known history of prior episodes of cholecystitis, prior biliary procedure or prior or
ongoing biliary disease.
- Unable to take oral medications.
- Not recovered from previous therapies.
- Major surgery within 28 days prior to enrollment.
- Prior malignancy unless treated with curative intent and without evidence of disease
for greater than 3 years before enrollment.
- Peripheral neuropathy grade > 1 per CTCAE version 3.0