Condition: Anatomic Stage IV Breast Cancer AJCC v8 · Metastatic Triple-Negative Breast Carcinoma · Sponsor: Yuan Yuan
This phase II trial studies the side effects and best dose of ivermectin in combination with balstilimab or pembrolizumab and to see how well they they work in shrinking tumors in patients with triple negative breast cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as balstilimab or pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivermectin may help block the formation of growths that may become cancer. Giving ivermectin with balstilimab or pembrolizumab may increase the effect of balstilimab or pembrolizumab in shrinking tumors in patients with triple negative breast cancer. The secondary objectives of the study include evaluating the following efficacy outcomes: objective response rate (ORR), progression free survival (PFS), overall survival (OS), duration of response (DOR), clinical benefit rate (CBR), and patients' quality of life (QOL) by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).
This description comes directly from the study's public registry record.
Clinical Trial Navigator · 3104232133 · GroupCancerTrialInformation@cshs.org
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| Cedars-Sinai Medical Center | Los Angeles, California, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05318469