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Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington Identifier:
First received: January 13, 2009
Last updated: August 8, 2016
Last verified: August 2016
This phase II trial is studying the side effects of giving topical imiquimod together with Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) to see how well it works in treating patients with advanced breast cancer. Biological therapies, such as imiquimod, may stimulate the immune system to kill tumor cells. Drugs used in chemotherapy, such as Abraxane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imiquimod together with Abraxane may kill more tumor cells.

Condition Intervention Phase
Male Breast Cancer
Recurrent Breast Cancer
Skin Metastases
Stage IV Breast Cancer
Drug: imiquimod
Drug: Abraxane
Other: laboratory biomarker analysis
Genetic: RNA analysis
Other: immunoenzyme technique
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Topical Imiquimod and Weekly Abraxane for the Treatment of Breast Cancer Cutaneous Metastases

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Anti-tumor effects of imiquimod as assessed by modified World Health Organization (WHO) criteria [ Time Frame: Baseline and then every 4 weeks until week 24 ]
    Tumor responses will be determined using the sum of the products of the largest perpendicular dimensions. Target lesions will be evaluated by the following response criteria: complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).

  • Safety and systemic toxicity as assessed by a review of medical history, physical exam, systems, performance status, and clinical labs (CBC and CMP) [ Time Frame: Baseline and weeks 5, 9 13, 16, 20, and 24 ]
    Evaluated according to the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 and monitoring of adverse events will be done per Food and Drug Administration (FDA) and National Cancer Institute (NCI) guidelines

  • Pathologic response as assessed by skin punch biopsy [ Time Frame: Pre-and post-treatment ]

Secondary Outcome Measures:
  • Endogenous immunity to common breast tumor antigens (HER2, IGFBP-2, Topoisomerase II-alpha, and p53) in peripheral blood as assessed by IFN-gamma and ELISPOT assay [ Time Frame: Baseline and at weeks 13 and 24 ]
  • Incidence of reduction of serum TGF-beta levels as assessed by ELISA and correlation with Th1 adaptive immunity and clinical response [ Time Frame: Baseline and at weeks 13 and 24 ]

Estimated Enrollment: 15
Study Start Date: December 2008
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (biological therapy, chemotherapy)
Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Drug: imiquimod
Given topically
Other Names:
  • Aldara
  • IMQ
  • R 837
Drug: Abraxane
Given IV
Other Names:
  • Albumin-Stabilized Nanoparticle Paclitaxel
  • nab paclitaxel
  • nab-paclitaxel
  • nanoparticle albumin-bound paclitaxel
  • Nanoparticle Paclitaxel
  • paclitaxel albumin-stabilized nanoparticle formulation
Other: laboratory biomarker analysis
Correlative studies
Genetic: RNA analysis
Correlative studies
Other: immunoenzyme technique
Correlative studies
Other Name: immunoenzyme techniques

Detailed Description:


I. To evaluate the safety of chemoimmunotherapy with topical imiquimod and Abraxane in breast cancer patients with recurrent chest wall disease or cutaneous metastasis.

II. To evaluate the anti-tumor effects of chemoimmunotherapy with topical imiquimod and Abraxane in breast cancer patients with recurrent chest wall disease or cutaneous metastasis.


I. To examine whether treatment with chemoimmunotherapy consisting of topical imiquimod and Abraxane augments endogenous tumor specific immunity.

II. To assess the effect of chemoimmunotherapy on circulating transforming growth factor (TGF)-beta levels.


Patients receive Abraxane intravenously (IV) over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions once daily (QD) on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 4, 8, and 12 weeks.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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, lapatinib and/or hormonal therapy are eligible
  • White blood cell count >= 1000/ul
  • Absolute neutrophil count (ANC) >= 1200/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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00821964

United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Lupe Salazar Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Washington Identifier: NCT00821964     History of Changes
Other Study ID Numbers: 6578
NCI-2010-00040 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
R01CA138521 ( US NIH Grant/Contract Award Number )
131 ( Other Identifier: Tumor Vaccine Group )
Study First Received: January 13, 2009
Last Updated: August 8, 2016

Keywords provided by University of Washington:
Breast Cancer
Stage IV

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers processed this record on April 28, 2017