Clinical setting | Trial phase | Intervention | N | Biological endpoints | NCT protocol # |
---|---|---|---|---|---|
Neoadjuvant PBC: (HER2+ only) | II | GEF × 2 weeks followed by GEF+TAM | 45 | Tumor biomarker analysis at weeks 1, 2, 6 and surgery | 00206492 |
Neoadjuvant PBC | II | ANA + FUL + GEF | 40 | Tumor biomarker analysis pre- and post-treatment | 00206414 |
MBC | II RCT | TAM +/-GEF | 274 | Correlate RR to HER2/A1B1 status and other biomarker studies | 00069290 |
MBC | II RCT | ANA+/- GEF | 174 | biomarker study | 00077025 |
MBC | II RCT | ANA +/- GEF | 108 | None specified | 00066378 |
MBC | II | FUL+GEF | 60 | None specified | 00234403 |
MBC | II RT | ANA+GEF vs FUL+GEF | 148 | Identify biologic predictors | 00057941 |
MBC | II | LET +ERL | 150 | Correlation of EGFR, HER2 and pERSer118 to benefit | 00179296 |
MBC: TAM resistant | II RT | GEF+/-TAM | 46 | Correlate early changes on PET and in plasma DNA to response | 00080743 |
With Trastuzumab | |||||
HER2+ MBC: AI-resistant | II | TRAS monotherapy until PD followed by TRAS + LET | 40 | Correlate benefit with HER2 ECD at baseline and after treatment | 00238290 |
HER2+ MBC | III RCT | ANA+/- TRAS | NA | None specified | 00022672 |
HER2+ MBC: TRAS-naive | IV | LET+ TRAS | 370 | None specified | 00171847 |
With Lapatinib (LAP) | |||||
MBC: TAM-resistant | II | LAP+TAM | 41 | None specified | 00118157 |
MBC | III RCT | LET +/- LAP | 128 | Biomarker and genetic variant analysis | 00073528 |
MBC: HER2 1+, 2+, 3+ or FISH+ | III RCT | FUL+/-LAP | 324 | None specified | 00390455 |
With FTIs: lonafarnib (LON) and tipifarnib (TIP) | |||||
MBC | II RCT | ANA +/-LON | 124 | None specified | 00081510 |
MBC | II RCT | ANA +/- LON | 110 | None specified | 00098904 |
MBC | II RCT | LET+ TIP (continuous) vs LET + TIP (intermittent) vs LET | 108 | None specified | 00061971 |
MBC | II | TAM + TIP | 27–40 | Note: efficacy stratified according to benefit from prior hormone tx | 00052728 |
MBC | II | FUL + TIP | 45 | Efficacy and toxicity | 00082810 |
With mTOR inhibitors: everolimus (EVE) and temsirolimus (TEM) | |||||
Neoadjuvant PBC | II RCT | LET+/-EVE | 255 | None specified | 00107016 |
MBC | II RCT | LET+/-TEM | 90 | None specified | 00061971 |
With angiogenesis inhibitors: Bevacizumab (BEV), vatalanib (VAT) | |||||
Neoadjuvant PBC | II | LET+BEV | 25 | None specified | 00161291 |
MBC: With acquired endocrine resistance* | II | BEV will be added to current endocrine therapy | 30 | Correlate metabolic response by PET to clinical benefit | 00240071 |
MBC | II | BEV+LET | 42 | Tumor biomarker analysis Correlate serial endothelial and epithelial cell measurements to response and markers of angiogenesis | 00187694 |
MBC | II | BEV+ANA or FUL | 80 | None specified | 00405938 |
MBC | II | VAT+LET | 32 | None specified | 00263198 |
With multitargeted TKIs: sorafenib (SOR), imatinib (IMA) | |||||
MBC: AI-resistant | I/II | ANA +SOR | 50 | Assess changes in Raf and VEGF signalling in tumor and stroma | 00217399 |
MBC: PDGFR or c-kit + only | II | LET+IMA | 45 | Serum measurements of VEGF, bFGF, IL8, PDGF, TNF, E-selectin | 00338728 |
Combination with HDAC inhibitor SAHA | |||||
MBC | II | TAM+SAHA | 42 | Pre-and post treatment ER expression and histone acetylation | 00365599 |