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About
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which treatment regimen is more effective in treating women with breast cancer.
PURPOSE: This randomized phase II trial is studying paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin, cyclophosphamide, and pegfilgrastim to compare how well they work when given with or without bevacizumab in treating women with inflammatory or locally advanced breast cancer.
Full description
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to type of disease (inflammatory vs locally advanced breast cancer) and hormone receptor status (positive [estrogen receptor (ER)+ and/or progesterone receptor (PgR)+] vs negative [ER- and PgR-]). Patients are randomized to 1 of 3 treatment arms.
In all arms, patients with stable or responding disease undergo surgery 3-6 weeks after completion of chemotherapy. Patients may then undergo radiotherapy 5 days a week for 6 weeks.
Serum, whole blood, and tissue samples are collected periodically for biomarker analysis, circulating endothelial cell analysis, and pharmacogenomic studies, respectively.
After completion of study treatment, patients are followed every 6 months for 1 year and then annually for 4 years.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically or pathologically confirmed breast cancer meeting one of the following criteria:
Locally advanced disease (stage IIIB disease, stage IIB/IIIA, or stage IIIC disease)
Inflammatory disease meeting the following two clinicopathologic criteria:
HER2/neu-negative tumor as demonstrated by 0 or 1+ (weak or no staining) by DAKO, IHC, or equivalent test OR no gene amplification by FISH*
NOTE: *A negative FISH test ratio is < 1.8 or FISH HER2 gene copy < 4.0; if only a positive or negative result is available from the FISH test, a negative result is acceptable for study entry
Hormone receptor status known
PATIENT CHARACTERISTICS:
Menopausal status not specified
Zubrod performance status 0-2
Granulocyte count > 1,500/mm^3
ANC ≥ 1,500/mm^3
Platelet count > 100,000/mm^3
Hemoglobin 9.0 g/dL
Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
Bilirubin ≤ 1.5 mg/dL
ALT and AST ≤ 3 times ULN
Alkaline phosphatase ≤ 2.5 ULN (unless bone metastasis is present in the absence of liver metastasis)
Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg on 24-hour urine collection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to take oral medications (e.g., no uncontrolled nausea, vomiting, or diarrhea, lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome)
QTc < 500 msec by EKG
LVEF normal by MUGA or ECHO (for patients with hypertension or for patients > 60 years of age)
NYHA class II cardiac function by baseline ECHO/MUGA (for patients who have received central thoracic radiotherapy that included the heart in the radiotherapy port, or for patients who have a history of class II heart failure but are asymptomatic on treatment are eligible)
No history of stroke (cerebrovascular accident), transient ischemic attack, or cardiac event within the past 12 months, including any of the following:
No poorly controlled hypertension, defined as recurrent or persistent (≥ 24 hours) elevated blood pressure (i.e., systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg)
No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
Peripheral neuropathy < grade 2
PRIOR CONCURRENT THERAPY:
Primary purpose
Allocation
Interventional model
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215 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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