A Study of Biweekly Gemcitabine, Paclitaxel, and Avastin in Patients With Metastatic Breast Cancer

Inclusion Criteria

• Patient must be 18 years of age or older with histologically confirmed breast cancer and clinical evidence of metastatic disease.
• Patients must have measurable or non-measurable disease. X-rays, scans or physical examinations used to assess measurable disease must be performed within 28 days prior to registration. X-rays, scans or physical examinations to assess non-measurable disease must be completed within 42 days prior to registration. Patients with effusions or ascites as the only sites of disease are ineligible.
• Patients must meet the following requirements regarding prior and concurrent chemotherapy:Patients must not have received prior chemotherapy regimens for metastatic breast cancer. Patients may have received adjuvant/neoadjuvant chemotherapy, for a total of 3 prior regimens.
• Prior therapy with paclitaxel or docetaxel is allowed in the adjuvant or neoadjuvant setting, if given > 6 months prior to registration.
• Patients must have >14 days delay between the conclusion of any radiation and the start of gemcitabine, provided the acute effects of radiation treatment have resolved.
• Patients may have received any number of exogenous hormonal therapies and/or trastuzumab in the adjuvant, neoadjuvant or metastatic setting. Last dose of prior hormonal therapy at least 14 days prior to registration.
• Patients may receive concomitant bisphosphonate therapy for bone metastasis.
• Patients must have recovered from any prior surgery. Two weeks must have elapsed from the time of any minor surgery and 4 weeks of any major surgery.
• Patients must have adequate bone marrow reserve as evidenced by the following: ANC > 1500/mcL, platelets > 100, 000/mcL, and hemoglobin > 9.0 gm/dL. These results must be obtained within 28 days prior to registration.
• Patients must have serum creatinine 50% of the marrow-bearing bone.
• Patients must not have a history of significant symptomatic cardiac disease or left ventricular ejection fraction (LVEF) 150/100).
• Patients must not have pr-existing clinically significant (Grade 2 or greater per CTCAE Version 3.0 motor or sensory neuropathy except for abnormalities due to cancer.
• Patients known to be HIV positive.
• Patients must not be nursing or pregnant. Men and women of reproductive potential must agree to use an effective contraceptive method.
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or Stage II cancer from which the patient has been disease free for 5 years.
• Patients must not have had a Stroke or Myocardial Infarction in the past 6 months. Patients with unstable agina, significant peripheral vascular disease, history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within the last 6 months should be excluded.