Phase 2
Completed N=15
Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer
male breast cancer · Recurrent Breast Cancer · Skin Metastases · Stage IV Breast Cancer
Source: ClinicalTrials.gov NCT00821964 ↗
Enrolled (actual)
15
Serious AEs
6.7%
Results posted
Jun 2017
Primary outcomePrimary: Anti-tumor Effects of Imiquimod as Assessed by Modified World Health Organization (WHO) Criteria — 14; 5; 5; 3 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-tumor Effects of Imiquimod as Assessed by Modified World Health Organization (WHO) Criteria |
14; 5; 5; 3; 1 | — |
| PRIMARY Safety and Systemic Toxicity as Assessed by a Review of Medical History, Physical Exam, Systems, Performance Status, and Clinical Labs (CBC and CMP) |
15 | — |
| PRIMARY Pathologic Response by Immunohistochemical (IHC)as Assessed by Skin Punch Biopsy of the Target Lesion |
7; 5; 2 | — |
| SECONDARY 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 |
0; 0; 8; 3; 2; 1 | — |
| SECONDARY Incidence of Reduction of Serum TGF-beta Levels as Assessed by ELISA and Correlation With Th1 Adaptive Immunity and Clinical Response |
8; 0 | — |
Eligibility Criteria
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 = 60 ml/min
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = Grade 2
Data sourced from ClinicalTrials.gov (NCT00821964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.