Table 3.
Ongoing clinical trials for metastatic breast cancer with brain metastases.
| Treatment | ClinicalTrials.gov | Phase | Patients’ Population | Primary Endpoint |
|---|---|---|---|---|
| Neratinib + capecitabine | NCT04965064 | II | HER2- BCBM and abnormally active HER2 signaling | OS, CNS-PFS |
| Pyrotinib + vinorelbine | NCT03933982 | II | HER2+ BCBM | CNS-ORR |
| Palbociclib + trastuzumab + pyrotinib + fulvestrant | NCT04334330 | II | HR+/HER2+ BCBM | CNS-ORR |
| Pyrotinib + trastuzumab + abraxane | NCT04639271 | II | HER2+ BCBM | CNS-ORR, CNS-PFS |
| T-DXd | NCT04752059 | II | HER2+ BCBM | CNS-ORR |
| T-DXd | NCT04739761 | III | Advanced or metastatic HER2+ BC | ORR; PFS |
| GDC-0084 + trastuzumab | NCT03765983 | II | HER2+ BCBM | CNS-ORR |
| Trastuzumab + taxanes + pertuzumab vs. trastuzumab + taxanes + TKIs | NCT04760431 | II | HER2+ BCBM | CNS-ORR |
| ARX788 | NCT05018702 | II | HER2+ BCBM | CNS clinical benefit rate |
| T-DM1 + afatinib vs. T-DM1 | NCT04158947 | II | Active refractory HER2+ BCBM | Safety and tolerability of T-DM1 and afatinib; ORR |
| Trastuzumab/pertuzumab + tucatinib or T-DM1 + tucatinib | NCT05323955 | II | HER2+ BCBM | PFS |
| Phase I: T-DM1 + TMZ in dose escalation Phase II: T-DM1 vs. T-DM1 + TMZ |
NCT03190967 | I/II | HER2+ BCBM following SRS | MTD of temozolomide when used with T-DM; Median amount of time subject survives without disease progression after treatment. |
| Pyrotinib + capecitabine + brain radiotherapy | NCT04582968 | I/II | HER2+ BCBM | Assess safety and tolerability (Phase Ib part); Intracranial local tumor control rate (Phase II part) |
| SRT + pyrotinib + capecitabine vs. WBRT + pyrotinib + capecitabine | NCT05042791 | II | HER2+ BCBM | CNS-ORR |
| Abemaciclib + elacestrant | NCT04791384 | Ib/II | HR+/HER2+ BCBM | Adverse events; iORR |
| Utidelone + bevacizumab | NCT05357417 | II | BCBM | CNS-ORR |
| Nivolumab + SRS | NCT03807765 | Ib | BCBM | Number of participants who experience dose limiting toxicities |
| Abemaciclib + SRT | NCT04923542 | I/II | HR+/HER2- BCBM | CNS-PFS |
| Cycle 1: Olaparib + SRS Cycle 2 and 2+: Physician’s choice systemic therapy and durvalumab | NCT04711824 | I/II | TN or BRCA-mutated BCBM | Frequency and severity of adverse events; intracranial disease control rate |
| Liposomal irinotecan + pembrolizumab | NCT05255666 | II | TN BCBM | CNS disease control rate |
| Nal-IRI | NCT03328884 | II | Progressing HER2- BCBM | CNS-ORR |
| QBS72S | NCT05305365 | IIa | TN BCBM | CNS-ORR |
| ANG1005 | NCT02048059 | II | Recurrent BCBM | iORR |
| Bintrafusp alfa + pimasertib | NCT04789668 | I/II | BM | Clinical benefit rate; toxicities and dose-limiting toxicities; time to intracranial progression; OS |
| Anti-HER2/3 dendritic cell vaccine + pembrolizumab | NCT04348747 | II | TN or HER2+ BCBM | CNS-ORR |
| HER2-CAR T cells | NCT03696030 | I | HER2+ BCBM | Incidence of dose limiting toxicities; number of participants with treatment related adverse events |
BC, breast cancer; BCBM, breast cancer brain metastases; BM, brain metastasis; CNS, central nervous system; CAR, Chimeric Antigen Receptor; HR, hormone receptor; HER2, human epidermal growth factor receptor 2; iORR, intracranial objective response rate; nal-IRI, nanoliposomal irinotecan; OS, overall survival; ORR, objective response rate; PFS, progressionfree survival; SRS, stereotactic radiosurgery; SRT, stereotactic radiotherapy; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan; TN, triple negative; TTP, time to progression; WBRT, whole brain radiotherapy.