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SCCA Breast Cancer Clinical Trials

Phase II Topical Imiquimod/wkly Abraxane (6578)
Phase II Study of Topical Imiquimod (Aldara) and Weekly Abraxane for the Treatment of Breast Cancer Cutaneous Metastases
Status Conditions Phase Study ID
Closed Breast Cancer
Metastatic Cancer
Phase II 6578/131
NCT00821964
Summary

The purpose of this study is to evaluate the safety and effects, good or bad, of the drugs imiquimod and Abraxane® as treatment for advanced breast cancer with chest wall and/or skin metastases. The combined use of Abraxane® and imiquimod in this study is experimental.


Investigator
Lupe Salazar, MD
Location    
University of Washington - Tumor Vaccine Group 206-543-6620, TVGTrial@uw.edu  
Eligibility Criteria (must meet the following to participate in this study)
  • Patients must be at least 18 years of age
  • Patients with advanced stage refractory breast cancer
  • Progressive or relapsed disease following standard therapy with chemotherapy and/or surgery, and/or radiation
  • Patients must have measurable (bi-dimensional) chest wall disease and/or cutaneous metastatic lesions
  • Patients must be at least 7 days from last chemotherapy and 30 days from local radiotherapy and/or systemic steroids
  • Patients on bisphosphonates, trastuzumab (herceptin), lapatinib (Tykerb) and/or hormonal therapy are eligible
  • White blood cells (WBC) >= 1,000/ul
  • Absolute neutrophil count (ANC) >= 1,200/ul
  • Platelets > 75,000/ul
  • Serum creatinine =< 2.0 mg/dL, a creatinine clearance > 60 ml/min
  • Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) < 2 X upper limit normal (ULN)
  • Total bilirubin < 2 X ULN
  • Patients must have a Performance Status Score (Eastern Cooperative Oncology Group [ECOG] Scale) =< 2
  • Patients must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment
  • Men and women of reproductive ability must agree to contraceptive use during the study and for 1 month after imiquimod/Abraxane treatment is discontinued
Exclusions (conditions that would prevent participation in this study)
  • Patients with prior allergic reaction to taxanes
  • Patients with any clinically significant active autoimmune disease requiring active treatment with systemic steroids or other immunomodulators
  • Pregnant or breast-feeding women
  • Patients with peripheral neuropathy >= Grade 2
Last Updated
November 06, 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.