Table 1.
Current Clinical Trials Involving Patients with Triple-Negative Breast Cancer with Brain Metastasis
| Treatment/ Target | Phase/Arms/Centers | Intervention | Control Arm/ Other Arms | Clinical Trials.Gov ID | Comments |
|---|---|---|---|---|---|
| Radiation therapy | Phase III, Randomized, Multi-arm Multicenter | Prophylactic cranial irradiation | Observation | NCT02448576 | |
| Radiation therapy | Phase I, Single-arm, Single-center | Stereotactic Body Radiation Therapy + JS001 | None | NCT03151447 | |
| Chemotherapy | Phase II, Prospective, Multi-arm, Multicenter, Multi-cohort | Cisplatin+ Placebo | Cisplatin +Veliparib | NCT02595905 | |
| Topoisomerase I inhibitors | Phase I, single-arm, Multiphase, Multi-center, multi-cohort | MM-398 (Nanoliposomal Irinotecan) | None | NCT01770353 | Includes brain metastasis from Colorectal cancer, TNBC, ER/PR positive breast cancer, non-small cell lung cancer, pancreatic cancer, ovarian cancer, gastric cancer, gastroesophageal junction adenocarcinoma, head, and neck cancers. |
| PDL1 | Phase I/Phase II, prospective, Single-Arm, Single Center | Bintrafusp Alfa+ Pimasertib | None | NCT04789668 | Includes brain metastasis from Melanoma, hematopoietic and lymphoid cell neoplasm, HR+ breast adenocarcinoma |
| PDL1 | Phase II, Prospective, Single arm, Single Center | Nivolumab+Ipilimumab | None | NCT04434560 | |
| PD-L1 | Phase II, Single arm, Single center | Atezolizumab + Stereotactic radiation | None | NCT03483012 | |
| Multivalent heteroclitic peptide immunotherapeutic vaccine | Phase I/Phase II, prospective, Single-Arm, Single Center | Galinpepimut-S+Pembrolizumab (4 arms evaluating brain metastases from different cancers) | None | NCT03761914 | |
| Dendritic Cell Vaccine/Anti-HER 2/ Anti-HER 3 | Phase IIa, Single-arm, Single-center | Anti-HER2/HER3 Dendritic cell vaccine + Celecoxib+ Pembrolizumab+ Recombinant Interferon Alfa-2b | None | NCT04348747 | |
| Humanized IgG4 monoclonal antibody | Phase II, Prospective, Single-arm, Single-center, Multi cohort | SHR-1316+Bevacizumab+cisplatin/carboplatin | Pyrotinib+Temzolomide in HR+/HER2+ patients | NCT04303988 | |
| Antibody-drug conjugate | Phase II, Prospective, Single-arm, Single-center, Single cohort. | Sacituzumab Govitecan | None | NCT04647916 | |
| Antibody-drug conjugate | Early Phase-I, Single-arm, Single-center, multi-cohort | Sacituzumab Govitecan | None | NCT03995706 | Includes breast cancer patients with known or suspected parenchymal metastases and patients with recurrent glioblastoma that has progressed after radiation and temozolomide. |
| Antibody-drug conjugate | Phase III, Randomized, Multi-arm Multicenter | Sacituzumab Govitecan | Eribulin + Capecitabine + Gemcitabine+ Vinorelbine | NCT02574455 |
Notes: JS001 (anti-PD-L1 antibody), SHR-1316 (anti-PD-L1 antibody).
Abbreviations: PDL-1, Programmed death-ligand 1; Anti-HER 2, Anti-human epidermal growth factor receptor 2; Anti-HER 3, Anti-human epidermal growth factor receptor 3; IgG4, Immunoglobulin G4; E.R., Estrogen Receptor; PR, Progesterone Receptor; HR+, Hormone Receptor positive.