Ivermectin and Balstilimab for the Treatment of Metastatic Triple Negative Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8Metastatic Triple-Negative Breast CarcinomaThis phase II trial studies the side effects and best dose of ivermectin in combination with balstilimab 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, 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 may increase the effect of balstilimab 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).
Huaier Granule in Treating Women With Triple Negative Breast Cancer
Triple Negative Breast CancerRATIONALE: Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely used in China for many years. The investigators previous study has reported that Huaier could exert great inhibitory effects on breast cancer cells both in vitro and in vivo. PURPOSE: To evaluate the efficacy and safety of Huaier Granule in treating women who have triple negative breast cancer that has been surgically removed.
Comparing Sequential Neoadjuvant Treatment Including Chemotherapy and Accelerated Radiation Focused...
Radiation TherapyBreast Cancer2 moreIn the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and CT administered sequentially in patients with intermediate ad high risk BC. The hypothesis is that combined PST-sequential APBI may increase the rate of pCR, breast conservation and survival without additional toxicity, as seen with WBI
Safety Study of MELK Inhibitor to Treat Patients With Advanced Breast Cancer and Triple Negative...
Relapsed/Refractory Locally Advanced or Metastatic Breast Cancer and Triple Negative Breast CancerThe purpose of this study is to determine the maximum tolerated dose (MTD) of OTS167 administered via oral capsule (PO) to patients with relapsed/refractory locally advanced or metastatic breast cancer.
Combination of Olaparib and Navitoclax in Women With HGSC and TNBC
High Grade Serous CarcinomaTriple Negative Breast Cancer1 moreThe purpose of this Phase I study is to determine if the PARP inhibitor olaparib can be safely combined with navitoclax, an inhibitor of Bcl-2/Bcl-XL, in women with TNBC who have somatic or germline mutations in breast cancer gene one (BRCA1) and breast cancer gene two (BRCA2) BRCA1/2 or PALB2 and in women with recurrent HGSC who have progressed greater than 6 months since their last platinum containing chemotherapy. The trial is designed as an open- label multi-center Phase I interventional and translational study. It will identify the dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and RP2D of olaparib combined with navitoclax for study in Phase II. There is a plan for a follow on Phase II study depending on the results obtained during this Phase I trial.The rationale for this study is that for a subset of patients, olaparib, will increase tumor cell survival dependence on inhibition of cell death by Bcl 2/Bcl- XL. Thus, navitoclax will augment apoptosis induced by PARP inhibition with olaparib.
Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic...
Chronic Lymphocytic LeukemiaMantle Cell Lymphoma3 moreThe purpose of the study is to find out if an investigational drug called PRGN-3007 UltraCAR-T cells (PRGN-3007 T cells) can help people with ROR1-positive hematologic chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL) and solid tumor triple negative breast cancer (TNBC) malignancies.
A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative...
Triple Negative Breast CancerHER2-positive Breast CancerAdjuvant radiotherapy is the standard treatment for early breast cancer after breast conserving surgery. Molecular subtypes was significantly associated with the risk of local recurrence of breast cancer. Nguyen et al found that the overall 5-year cumulative incidence of local recurrence was 0.8% for luminal A, 1.5% for luminal B, 8.4% for HER2 positive, and 7.1% for triple negative breast cancer after lumpectomy and radiotherapy. Her2 positive and triple negative breast cancers may be inherently radioresistant. Therefore, for HER2 positive and triple negative breast cancer with high local recurrence and radiation resistance, proton combined with carbon ion is proposed after breast conserving surgery.
Neoadjuvant Fluzoparib in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer
TNBC - Triple-Negative Breast CancerAlthough many PARP inhibitors did not improve pCR in neoadjuvant studies, it is not an unchallenged conclusion that TNBC does not benefit from use of PARP inhibitors in neoadjuvant therapy.This study is an open-label, two-cohort, multicenter trial. 60 patients with germline BRCA-mutated three-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with chemotherapy according to tumor response after EC (epirubicin and cyclophosphamide) for 2 cycles.
Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC
Triple Negative Breast CancerBreast CancerThis study will assess if the presence of immune system cells in and around the tumor impacts tumor shrinkage in patients receiving neoadjuvant chemoimmunotherapy for triple-negative breast cancer.
Cemiplimab in High Risk or Locally Advanced Hormone Receptor Positive HER2 Negative or Triple-Negative...
Invasive Breast CancerThis is a single-arm, open-label, phase 2 study that will enroll 36 subjects, who have pathologically proven diagnosis of invasive breast cancer, clinical stage tumor 1-3 (cT1-T3), node 0-3 (cN0-N3), metastasis 0 (cM0), hormone receptor positive (HR+) (estrogen-receptor-positive (ER+) and/or progesterone-receptor-positive (PR+) human epidermal growth factor receptor 2 (HER2) negative or hormone receptor-negative (HR-) (estrogen-receptor-negative (ER-) and progesterone-receptor-negative (PR-) human epidermal growth factor receptor 2 (HER2) negative/triple-negative breast cancer.