Table 5:
Details of Phase III trials (n = 8) and associated Phase II trials
| Intervention | Phase IIII NCTID |
Indication | Phase III Status |
Phase III Completion Date |
N (III) |
Endpoint (III) | Result | Preceding Phase II? |
Phase II NCTID |
N (II) |
Endpoint (II) | Randomized? | Start of Phase II to End of Phase III (months) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tucatinib + Trastuzumab | NCT03975647 | HER2+ BCBM | Recruiting | April 2024 | 460 | Progression-Free Survival | - | Yes | NCT02614794 | 612 | Progression-Free Survival | Yes | 56 |
| Atezolizumab + Surgery | NCT03281954 | Triple Negative BCBM | Recruiting | December 2023 | 1520 | Progression-Free Survival | - | Yes | NCT03483012 | 45 | Progression-Free Survival | No | 67 |
| Pertuzumab + Trastuzumab + Paclitaxel + Atezolizumab | NCT03199885 | HER2+ BCBM | Recruiting | December 2020 | 600 | Progression-Free Survival | - | Yes | NCT03125928 | 50 | Adverse Events | No | 42 |
| Lapatinib + Capecitabine vs Trastuzumab + Capecitabine | NCT00820222 | HER2+ BCBM | Completed | June 2012 | 540 | Progression-Free Survival | No difference between regimens | Yes | NCT00967031 | 45 | Objective Response Rate | No | 38 |
| Lapatinib + Trastuzumab | NCT00490139 | HER2+ BCBM | Active, not recruiting | December 2013 | 8382 | Progression-Free Survival | Did not meet anticipations | Yes | NCT00470704 | 116 | Objective Response Rate | No | 79 |
| SRS + WBRT | NCT00377156 | BCBM | Active, not recruiting | October 2014 | 213 | Neurocognitive Progression | Less cognitive deterioration | Yes | NCT01227954 | 113 | Delay in Recall | No | 43 |
| WBRT + Oxygen + Efaproxiral | NCT00083304 | BCBM | Completed | June 2007 | 368 | Overall Survival | - | Yes | NCT00004202 | - | Overall Survival | - | 104 |
| Lapatinib + Letrozole | NCT00073528 | ER+ BCBM | Completed | June 2008 | 1285 | Progression-Free Survival | Increased progression-free survival | Yes | NCT00422903 | 92 | Objective Response Rate | Yes | 14 |