Trial Information

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

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
Email: janeen.bazan@shermanhospital.org

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Research Center Information: Sherman Health

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