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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

Overview

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

Purpose

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
    Phase

    3

    Gender

    Both Male and Female

    Age

    N/A

    Overall Status

    Recruiting

    Facility Type

    N/A

    Contact

    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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