Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer
Condition: Inflammatory Breast Cancer; Male Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
MeSH terms: Breast Neoplasms; Breast Neoplasms, Male; Inflammatory Breast Neoplasms
Intervention: sunitinib malate; paclitaxel; doxorubicin hydrochloride; cyclophosphamide; filgrastim; therapeutic conventional surgery; laboratory biomarker analysis; flow cytometry
Intervention description: Given PO; Given IV; Given IV; Given PO; Given SC; Undergo surgery; Correlative studies; Correlative studies
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Healthy volunteers: No

Summary:

      This phase II trial studies how well giving sunitinib malate together with paclitaxel,
      doxorubicin hydrochloride, and cyclophosphamide before surgery works in treating patients
      with stage IIB-IIIC breast cancer. Sunitinib malate may stop the growth of tumor cells by
      blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
      Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and
      cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing
      the cells or by stopping them from dividing. Giving sunitinib malate together with
      combination chemotherapy before surgery may make the tumor smaller and reduce the amount of
      normal tissue that needs to be removed
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be informed of the investigational nature of the study and all pertinent aspects of
             the trial and must sign and give written consent in accordance with institutional and
             federal guidelines

          -  Have a histologically-confirmed diagnosis of breast cancer that is locally advanced or
             inflammatory; inflammatory breast cancer is defined as erythema and peau d'orange
             involving half or more of the breast with a histologic diagnosis of breast cancer; the
             finding of focal dermal lymphatic involvement on histology does not constitute
             inflammatory breast cancer

          -  Have selected stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0 or T0-2, N2, M0) disease
             judged primarily unresectable by an experienced breast surgeon or otherwise deemed
             appropriate candidates for neoadjuvant treatment or stage IIIB (T4, any N, M0) or
             stage IIIC (any T, N3, M0) disease

          -  Patients must have a performance status of 0-2 by Zubrod criteria

          -  Absolute neutrophil count (ANC) >= 1,500 cells/mm^3

          -  Platelet count >= 100,000 cells/mm^3

          -  Serum creatinine =< 1.5 x institutional upper limit of normal (IULN)

          -  Bilirubin =< 2.0

          -  Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase
             (SGPT)/alkaline phosphatase =< 2.0 x IULN

          -  Have a multi gated acquisition scan (MUGA) or echocardiogram scan performed within 3
             months prior to enrollment and have a left ventricular ejection fraction (LVEF) %
             greater than the institutional lower limit of normal

          -  Be willing and able to comply with scheduled visits, treatment plan, laboratory tests
             and other trial procedures

        Exclusion Criteria:

          -  Have evidence of distant metastases

          -  Have tumors that overexpress human epidermal growth factor receptor 2 (HER2)/neu as
             evidenced by 3+ staining by immunohistochemistry or gene amplification by fluorescent
             in situ hybridization (FISH)

          -  Have received any prior chemotherapy or hormonal therapy for breast cancer

          -  Have received prior radiation therapy or prior definitive surgery for breast cancer

          -  Have a clinical diagnosis of congestive heart failure or angina pectoris or any of the
             following within the 6 months prior to study drug administration:, myocardial
             infarction, coronary/peripheral artery bypass graft, cerebrovascular accident or
             transient ischemic attack, or pulmonary embolism

          -  Have ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Toxicity
             Criteria for Adverse Events (CTCAE) version 3.0 grade >= 2

          -  Have uncontrolled hypertension (>150/100 mm Hg despite optimal medical therapy)

          -  Have pre-existing thyroid abnormality with thyroid function that cannot be maintained
             in the normal range with medication

          -  Have a known, active infection

          -  Have any prior malignancy except for adequately treated basal cell or squamous cell
             skin cancer, any in situ cancer, adequately treated stage I or II cancer from which
             the patient is currently in complete remission or any other cancer from which the
             patient has been disease-free for 5 years

          -  Human immunodeficiency virus (HIV) positive

          -  Are receiving or planning to receive any concurrent anticancer therapy while receiving
             protocol treatment

          -  Are receiving or planning to receive concurrent treatment on another clinical trial
             (supportive care trials or non-treatment trials, e.g. quality of life (QOL) are
             allowed; participation in the companion imaging trial, dynamic contrast
             enhanced-magnetic resonance imaging (DCE-MRI) and fludeoxyglucose F 18 positron
             emission tomography (FDG PET) with Kinetic Analysis to Monitor Breast Cancer Response
             to Neoadjuvant Sunitinib and Metronomic Chemotherapy is also allowed)

          -  Be pregnant or breast feeding; female subjects must be surgically sterile or be
             postmenopausal, or must agree to use effective contraception during the period of
             therapy; all female subjects with reproductive potential must have a negative
             pregnancy test (serum or urine) prior to enrollment; male subjects must be surgically
             sterile or must agree to use effective contraception during the period of therapy; the
             definition of effective contraception will be based on the judgment of the principal
             investigator or a designated associate

          -  Have other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or study
             drug administration, or may interfere with the interpretation of study results, and in
             the judgment of the investigator would make the subject inappropriate for entry into
             this study