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Therapeutic Areas: Oncology | Obstetrics/Gynecology (Women’s Health) | Family Medicine
Disease Category: Breast Cancer
Location: United States, IL

Clinical Trial Details


Research Study Summary

SWOG S0800 Phase II Randomized Study of Neoadjuvant Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Doxorubicin Hydrochloride, Cyclophosphamide, and Pegfilgrastim With Versus Without Bevacizumab in Women With HER2/neu-Negative Inflammatory or Locally Advanced Breast Cancer


To compare the pathologic complete response rates in women with HER2/neu-negative inflammatory or locally advanced breast cancer treated with paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin hydrochloride, cyclophosphamide, and pegfilgrastim with vs without bevacizumab.

Patient Inclusion Criteria:

  • Histologically or pathologically confirmed breast cancer meeting one of the following criteria:
    1. Locally advanced disease (stage IIIB disease, stage IIB/IIIA, or stage IIIC disease)

  • Inflammatory disease meeting the following two clinicopathologic criteria:
    1. Diffuse erythema AND edema (peau d’orange) of the breast involving the majority of the skin of the breast, i.e., more than 50%
    2. A biopsy demonstrating cancer either within the dermal lymphatics OR in the breast parenchyma itself

  • 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*
  • 2+ by DAKO or IHC allowed provided FISH* negative [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 Exclusion Criteria:

  • No prior tyrosine kinase inhibitors
  • More than 5 years since prior chemotherapy, radiotherapy, or biologic therapy (e.g., trastuzumab or bevacizumab) for invasive breast cancer
  • At least 7 days since prior hormonal therapy
  • At least 7 days since prior and no concurrent strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or grapefruit juice
  • No concurrent CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's wort)
  • No other concurrent therapy for the treatment of breast cancer except for bisphosphonates
  • No concurrent brachytherapy
  • To Learn more



    Both Male and Female



    Overall Status


    Facility Type



    Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
    Sherman Health
    1425 North Randall Road
    Elgin, IL 60123
    Phone: 224-783-2907
    Fax: 224-783-3071

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    If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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    CW ID: 183094

    Date Last Changed: September 6, 2012

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