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SCCA Breast Cancer Clinical Trials

Pfizer Sutent (6488)
A Phase II Study Evaluating the Safety and Efficacy of Sunitinib Maleate (Sutent) in Combination With Weekly Paclitaxel (Taxol) Followed by Doxorubicin (Adriamycin) and Daily Oral Cyclophosphamide (Cytoxan) Plus G-CSF as Neoadjuvant Chemotherapy for Locally Advanced or Inflammatory Breast Cancer
Status Conditions Phase Study ID
Closed Breast Cancer Phase II 6488
NCT00513695
Summary

The purpose of this study is to determine the safety and effectiveness of an investigational drug treatment for patients with locally advanced or inflammatory breast cancer. In this research study, an investigational drug called sunitinib will be added to the current, standard (non-research) drug treatment for locally advanced or inflammatory breast cancer.

Participants will receive treatment at the Seattle Cancer Care Alliance (SCCA) outpatient clinic. If hospitalization is needed while in Seattle, participants will be admitted to the University of Washington Medical Center (UWMC).

Treatment on this study will last about 6 months. Surgery, which is not a part of this study treatment, is expected to take place about a month after completion of this study treatment.

Follow-up may continue for up to five years after treatment has stopped.


Investigator
Jennifer Specht, MD
Location    
SCCA Breast Cancer Clinical Trials Program 800-804-8824 Refer Patient
Bozeman Deaconess Cancer Center, Bozeman, MT 406-585-5070  
Cascade Cancer Center, Kirkland WA 425-285-3928  
Olympic Medical Center, Sequim WA 360-683-9895  
Providence Alaska Medical Center, Anchorage AK 907-212-3109  
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • 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 NOTE: *The finding of focal dermal lymphatic involvement on histology does not constitute inflammatory breast cancer
  • Meets 1 of the following criteria:

    • 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 and patient is otherwise deemed an appropriate candidate for neoadjuvant treatment
    • Stage IIIB or IIIC (T4, any N, M0 or any T, N3, M0) disease
  • Hormone receptor status not specified

Exclusion criteria:

  • Evidence of distant metastases
  • Tumors that overexpress HER-2/neu as evidenced by 3+ staining by immunohistochemistry or gene amplification by FISH

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Male or female
  • Menopausal status not specified
  • Zubrod performance status 0-2
  • ANC ≥ 1,500 cells/mm³
  • Platelet count ≥ 100,000 cells/mm³
  • Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 2.0 mg/dL
  • SGOT/SGPT/alkaline phosphatase ≤ 2.0 times ULN
  • LVEF > institutional lower limit of normal by MUGA or echocardiogram
  • Not pregnant or breast-feeding
  • Fertile patients must use effective contraception
  • Negative pregnancy test

Exclusion criteria:

  • Clinical diagnosis of congestive heart failure or angina pectoris or any of the following within 6 months prior to study drug administration:

    • Myocardial infarction
    • Cerebrovascular accident or transient ischemic attack
    • Pulmonary embolism
  • Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade ≥ 2
  • Uncontrolled hypertension (> 150/100 mm Hg despite optimal medical therapy)
  • Preexisting thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
  • Known, active infection
  • 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
  • Known to be HIV-positive
  • 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

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

  • Received any prior chemotherapy or hormonal therapy for breast cancer
  • Received prior radiation therapy or prior definitive surgery for breast cancer
  • Coronary/peripheral artery bypass graft within 6 months prior to study drug administration
  • Receiving or planning to receive any concurrent anticancer therapy while receiving protocol treatment
  • Receiving or planning to receive concurrent treatment on another clinical trial

    • Supportive care trials or non-treatment trials (e.g. quality of life trials) are allowed
    • Participation in the companion imaging trial, DCE-MRI and FDG-PET with Kinetic Analysis to Monitor Breast Cancer Response to Neoadjuvant Sunitinib malate and Metronomic Chemotherapy is also allowed
  • Use of agents with proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, or flecainide) is not permitted during the study
Last Updated
December 21, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.