A Pilot, Phase II, Multicenter, Open-Label, Prospective Evaluation of Docetaxel and Bevacizumab ± Trastuzumab in the First-Line Treatment of Patients With Metastatic Breast Cancer

Inclusion Criteria

The following information on clinical trials is provided for information purposes only to
allow participants and physicians to have an initial discussion about the trial. This
information is not intended to be complete information about the trial, to contain all
considerations that may be relevant to potential participation in the trial, or to replace
the advice of a personal physician or health professional.

INCLUSION CRITERIA:

1. Histologically or cytologically proven adenocarcinoma of the breast at first
diagnosis

2. Stage IV disease with at least one measurable lesion according to the RECIST criteria

3. HER2/neu positive as determined by 3+ immunohistochemistry (IHC) staining or
fluorescence in situ hybridization (FISH) positivity or negative tumors

4. Life expectancy of >/= 24 weeks

5. No prior chemotherapy for metastatic breast cancer. (Prior endocrine therapy is
permitted).

6. Prior neoadjuvant or adjuvant chemotherapy is permitted, or at least 12 months must
have elapsed since the neoadjuvant or adjuvant therapy. Subjects may have received
prior adjuvant anthracyclines (maximum cumulative dose, 360 mg/m^2 doxorubicin or 750
mg/m^2 epirubicin)

7. At least 4 weeks since prior surgery, radiotherapy, endocrine therapy, or
experimental drug therapy with complete recovery from the effects of these
interventions

8. It is recommended that all baseline staging should be completed within 35 days prior
to study entry. All subjects will have the following workup as applicable; CT scan of
brain, CT scan or MRI of chest and abdomen, and bone scan or PET scan. In cases of
positive bone or PET scans, bone X-ray evaluation and/or MRI is required to confirm
or exclude metastatic bone disease. Subjects with metastatic disease limited to bone
are ineligible unless at least one lytic lesion is measurable and can be followed by
RECIST criteria. Other tests may be performed as clinically indicated

9. Normal cardiac function must be confirmed by left ventricular ejection fraction
(LVEF) of >/= 50% or shortening fraction (multiple-gated acquisition [MUGA] scan or
echocardiography respectively). The result must be greater than the lower limit of
normal (LLN) for the institution.

10. Subjects receiving bisphosphonate therapy; however, if bisphosphonates were started
within <2 months prior to treatment the bone lesions will not be evaluated for
response, and the subjects must have another site of metastatic disease that is
either measurable or evaluable for response

EXCLUSION CRITERIA:

1. Prior chemotherapy for metastatic breast cancer

2. Prior treatment with bevacizumab or other anti-VEGF therapy

3. Concurrent treatment with any other non-protocol anticancer therapy with the
exception of radiation therapy as long as all target lesions being followed are not
in the radiation field and if HER2/neu positive, HER2/neu-directed therapy

4. Current or prior history of brain or leptomeningeal metastases

5. Presence of neuropathy >/= 2

6. Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically
significant (>/= Grade 2) peripheral vascular disease

7. History of any other malignancy within the past 5 years, with the exception of
non-melanoma skin cancer or carcinoma in-situ of the cervix

8. Clinically significant cardiovascular disease

9. Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal
condition increasing the risk of perforation; history of abdominal fistula,
gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to
beginning therapy

10. History of bleeding diathesis or coagulopathy