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Status:

COMPLETED

S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer

Lead Sponsor:

SWOG Cancer Research Network

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

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, eith...

Detailed Description

OBJECTIVES: * 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 ...

Eligibility Criteria

Inclusion

  • 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:
  • Diffuse erythema AND edema (peau d'orange) of the breast involving the majority of the skin of the breast, i.e., more than 50%
  • 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 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:
  • Myocardial infarction (including severe/unstable angina)
  • Coronary/peripheral artery bypass graft
  • Symptomatic congestive heart failure
  • Pulmonary embolism
  • 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:
  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2015

    Estimated Enrollment :

    215 Patients enrolled

    Trial Details

    Trial ID

    NCT00856492

    Start Date

    April 1 2010

    End Date

    December 1 2015

    Last Update

    June 27 2017

    Active Locations (366)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 92 (366 locations)

    1

    Providence Cancer Center at Providence Hospital

    Mobile, Alabama, United States, 36608

    2

    Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205

    3

    Alta Bates Summit Comprehensive Cancer Center

    Berkeley, California, United States, 94704

    4

    Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

    Burbank, California, United States, 91505