Table 2.
Ongoing clinical trials in patients with BCBM.
| Treatment | Population | Phase | Primary endpoint | Status | Results/Comments | Clinicaltrials.gov ID | |
|---|---|---|---|---|---|---|---|
| PREVENTION | PCI | HER2-positive | I | Safety, neurocognitive function | Completed | NCT00916877 | |
| PCI | HER2-positive | III | Incidence of BM in women receiving trastuzumab and chemotherapy | Completed | NCT00639366 | ||
| Lapatinib + capecitabine | HER2-positive | III | CNS metastasis as site of first relapse | Active | Not recruiting | NCT00820222 | |
| TREATMENT | Trastuzumab + BKM120 | HER2-positive | I | Adverse events and DLT | Active | Not yet recruiting | NCT01132664 |
| Trastuzumab + everolimus + vinorelbine | HER2-positive | II | Intracranial ORR | Recruiting | NCT01305941 | ||
| Trastuzumab + ARRY-380 | HER2-positive | I | Maximum tolerated dose of ARRY-380 with trastuzumab | Recruiting | NCT01921335 | ||
| Trastuzumab + GRN1005 | HER2-positive | II | Intracranial ORR | Recruiting | NCT01480583 | ||
| Lapatinib | HER2-positive | II | CNS ORR | Completed | NCT00098605 | ||
| Lapatinib + WBRT | Breast and lung cancer brain metastases | II | Response rate | Recruiting | NCT01218529 | ||
| Lapatinib + WBRT | HER2-positive | II | Response | Recruiting | NCT01622868 | ||
| Lapatinib + temozolomide | HER2-positive | I | MTD and DLT | Completed | NCT00614978 | ||
| Lapatinib + WBRT | HER2-positive | I | MTD | Completed | MTD of lapatinib when combined with WBRT: 1250 mg, PFS 4.8 months, OS 19 months | NCT00470847 | |
| Lapatinib + capecitabine | HER2-positive | II | ORR | Completed | NCT00967031 | ||
| Afatinib +/− vinorelbine | HER2-positive | II | Benefit at 12 weeks | Completed | NCT01441596 | ||
| Neratinib | HER2-positive | II | ORR | Recruiting | NCT01494662 | ||
| Bevacizumab + carboplatin | All subtypes | II | CNS ORR | Active | Not recruiting | NCT01004172 | |
| Bevacizumab + cisplatin + etoposide | All subtypes | II | ORR | Completed | NCT01281696 | ||
| ANG1005 | HER2-positive | II | Intracranial ORR | Recruiting | NCT02048059 | ||
| INIPARIB + irinotecan | Triple-negative | II | Efficacy as measured by intra or extracranial TTP | Completed | PARP inhibitor in combination with chemotherapy | NCT01173497 | |
| BKM120 + capecitabine | Triple-negative | II | Clinical benefit rate | Recruiting | NCT02000882 | ||
| Stereotactic radiotherapy + HER-2 therapy | HER2-positive | II | 6-month distant brain relapse rate | Not yet open for recruitment | NCT01924351 | ||
| Hippocampus-sparing WBRT | All subtypes | III | Cognitive toxicity | Recruiting | NCT01942980 | ||
| Bevacizumab + etoposide + cisplatin followed by WBRT | All subtypes | II | Brain specific PFS | Not yet open for recruitment | NCT02185352 | ||
| WBRT + temozolomide | Breast and lung cancer brain metastases | II | ORR | Not yet open for recruitment | NCT02133677 | ||
| Lapatinib following cranial radiotherapy | HER2-positive | II | Response to lapatinib | Ongoing | Not recruiting | NCT00263588 | |
| WBRT + sorafenib | All subtypes | I | MTD | Recruiting | NCT01724606 | ||
| Cabozantinib +/− trastuzumab | All subtypes | II | ORR | Not yet open for recruitment | NCT02260531 | ||
| Ado-trastuzumab emtansine+ Radiotherapy | HER2-positive | I | Optimal sequence | Ongoing | Not recruiting | NCT02135159 | |
| Abemaciclib | Hormone receptor positive | II | ORR | Not yet open for recruitment | NCT02308020 | ||
| Capecitabine + Radiotherapy | All subtypes | II | Best objective CNS response | Completed | NCT00977379 | ||
| Cabazitaxel | Breast cancer and lung cancer | II | Objective tumor response | Not yet open for recruitment | NCT02166658 | ||
| KD019 + trastuzumab | HER2 positive | Ib/IIa | Safety/Tolerability | Recruiting | NCT02154529 | ||
| Epothilone B | All subtypes | II | CNS PFS | Completed | NCT00450866 | ||
| TPI 287 | All subtypes | II | ORR | Recruiting | NCT01332630 |
PCI, prophylactic cranial irradiation; WBRT, whole brain radiotherapy; BM, brain metastases; CNS, central nervous system; MTD, maximum tolerated dose; DLT, dose-limiting toxicity; TTP, time to progression; PFS, progression-free survival; ORR, overall response rate.