Clinical trial · Interventional
Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer
Phase II Study of Topical Imiquimod and Weekly Abraxane for the Treatment of Breast Cancer Cutaneous Metastases
NCT00821964CI-TRIAL-00030999completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Male Breast Cancer | Male Breast Carcinoma | ALIAS | 0.90 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Skin Metastases | — | UNRESOLVED | — |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abraxane | Drug | Paclitaxel | ALIAS |
| imiquimod | Drug | Imiquimod | ALIAS |
| immunoenzyme technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| RNA analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (biological therapy, chemo)
- description
- 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.
- interventionNames
- Drug: imiquimod
- Drug: Abraxane
- Other: laboratory biomarker analysis
- Genetic: RNA analysis
- Other: immunoenzyme technique
Primary outcomes (3)
- measure
- Anti-tumor Effects of Imiquimod as Assessed by Modified World Health Organization (WHO) Criteria
- timeFrame
- Baseline and then every 4 weeks until week 24
- description
- 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). Evaluation of target lesions per modified WHO response criteria: * Complete response (CR): complete clearance (100%) of target lesion(s) * Partial response (PR): ≥ 50% decrease in target lesion size * Stable disease (SD): \< 50% decrease in target lesion size * Progressive (PD): ≥ 25% increase in target lesion size Overall Response Rate (ORR) determined at end of study treatment which was 1 week after cycle #3, unless patient was withdrawn from study. If patient was withdrawn from study, then ORR was determined after their last cycle of treatment received.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSalazar LG, Lu H, Reichow JL, Childs JS, Coveler AL, Higgins DM, Waisman J, Allison KH, Dang Y, Disis ML. Topical Imiquimod Plus Nab-paclitaxel for Breast Cancer Cutaneous Metastases: A Phase 2 Clinical Trial. JAMA Oncol. 2017 Jul 1;3(7):969-973. doi: 10.1001/jamaoncol.2016.6007. PMID 28114604