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Therapeutic Areas: Oncology | Obstetrics/Gynecology
Disease Category: Breast Cancer

Trial Information

Bevacizumab and Paclitaxel, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, or Ixabepilone in Treating Patients With Locally Recurrent, Stage IIIB, or Stage IV Breast Cancer

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation, and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which treatment regimen is more effective in treating patients with recurrent or metastatic breast cancer.

PURPOSE: This randomized phase III trial is studying bevacizumab to see how well it works when given together with paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation, or ixabepilone in treating patients with locally recurrent, stage IIIB, or stage IV breast cancer.

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer
• Stage IIIB or IV (locally recurrent or metastatic) disease not amenable to local therapy
• Measurable disease (target lesions), defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 2.0 cm with conventional techniques or as ≥ 1 cm with spiral CT scan
• No non-measurable lesions, including any of the following:
  • Ascites
  • Pleural/pericardial effusion
  • Inflammatory breast disease
  • Lymphangitis cutis/pulmonitis
  • Bone lesions
  • Leptomeningeal disease
  • Cystic lesions
  • Abdominal masses not confirmed and followed by imaging techniques
  • No prior chemotherapy regimen for metastatic or locally advanced breast cancer
  • HER2/neu status must be known
  • HER2- positive disease allowed, provided patient received prior trastuzumab (Herceptin®) or lapatinib (documentation of progression on HER2-directed therapy is not required)
  • Hormone receptor status must be known
  • Estrogen receptor (ER)- and progesterone receptor (PgR)-positive if ≤ 1% cells are positive
  • No progressing or untreated CNS metastases or leptomeningeal disease
  • History of resected brain metastases with stable MRI scans for 3 months including within the past 4 weeks allowed
  • History of gamma-knife radiosurgery or whole-brain radiation with stable MRI scans for 3 months, including within the past 4 weeks allowed

PATIENT CHARACTERISTICS:

• Menopausal status not specified
• ECOG (Zubrod) performance status 0-1
• Life expectancy ≥ 12 weeks
• Granulocytes ≥ 1,500/µL
• Platelet count ≥ 100,000/µL
• Creatinine ≤ 2.0 mg/dL
• Bilirubin < 1.5 mg/dL (unless due to Gilbert's syndrome)
• AST and ALT ≤ 2.5 times upper limit of normal
• Urine protein ≤ 1+
• Urine protein:creatinine ratio < 1 OR 24-hour urine < 1 g for urine protein ≥ 2
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• History of seizures allowed if well controlled with standard medication
• No history of hypersensitivity to paclitaxel or Cremophor® EL CTCAE grade ≥ 3
• No other active malignancy except nonmelanoma skin cancer (patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to have less than 30% risk of relapse)
• No history of abdominal fistula or intra-abdominal abscess within 6 months prior to study registration
• No history of gastrointestinal (GI) perforation within the past 12 months
• No history of significant bleeding episodes (e.g., hemoptysis, upper or lower GI bleeding) within the past 6 months
• No history of stroke or transient ischemic attack within the past 6 months
• No history of clinically significant cardiovascular disease including any of the following:
  • Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 90 mm Hg on antihypertensive medications
  • Prior history of hypersensitivity or hypertensive encephalopathy
  • History of myocardial infarction or unstable angina within past 6 months
  • NYHA congestive heart failure class II-IV
  • Symptomatic peripheral vascular disease
  • Significant vascular disease (e.g., aortic aneurysm or aortic dissection) or arterial thrombotic events
  • No serious, non-healing wound, ulcer, or bone fracture
  • No significant traumatic injury in the past 28 days
  • No peripheral neuropathy = grade 2

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Adjuvant or neoadjuvant taxane allowed, provided interval between completion of adjuvant therapy and disease recurrence is ≥ 12 months

At least 2 weeks since prior radiotherapy

At least 7 days since core biopsy or other minor surgical procedure

Vascular access device placement allowed

At least 28 days since prior major surgical procedure or open biopsy and fully recovered

Prior trastuzumab or lapatinib ditosylate for HER2-overexpressing tumors allowed

Prior bevacizumab allowed

Prior and concurrent bisphosphonate treatment allowed

No anticipated need for a major surgical procedure during the study

No concurrent palliative radiotherapy

No concurrent aprepitant

No concurrent pegfilgrastim

No other concurrent chemotherapy or anticancer hormone therapy

Concurrent full-dose anticoagulants allowed but patient must be on a stable dose of warfarin or low molecular weight heparin

Anti-platelet therapy or on daily prophylactic-dose aspirin allowed

Stable doses of anticoagulation for atrial fibrillation allowed

Patricia Green Sharpe MSN MHSA RN, Director, Department of Clinical Trials/Oncology Data Services
Memorial Health University Medical Center
William & Iffath Hoskins Center for Biomedical Research & Education at Memorial Health University Medical Center
4700 Waters Avenue
Savannah, GA 31404
Phone: 912 350-7887
Fax: 912 350-8183
EMail: sharppa1@memorialhealth.com

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