Table 2.
Recent recruiting trials in IBC. Abbreviations are as follows: T, tumor stage; N, nodal; FEC, fluorouracil epirubucin cyclophosphamide; pCR, pathological complete response; MTD, maximum tolerated dose; PFS, progression-free survival; DCR, disease control rate; PD, progressive disease.
Trial name | Study population | Phase | Study target | Treatment arms | Primary outcome |
---|---|---|---|---|---|
NCT01880385 | T4d, any N stage, IBC | I | 30 | Open-label neoadjuvant bevacizumab + FEC followed by adjuvant docetaxel (+/−trastuzumab in HER2 positive) and RT | pCR |
NCT02623972 | HER2-negative, locally advanced IBC | II | 25 | Neoadjuvant eribulin followed by doxorubicin and cyclophosphamide | pCR |
NCT01938833 | Metastatic, HER2-negative IBC | I/II | 47 | Romidepsin and Nab-paclitaxel until PD or unacceptable toxicity |
MTD and PFS |
NCT02389764 | Metastatic, HER2-negative IBC | II | 44 | Oral nintedanib | CBR |
NCT00820547 | T4d, any N (stage IIIB or IIIC), HER2-negative IBC | II | 100 | Neoadjuvant FEC + bevacizumab followed by adjuvant docetaxel + 12 months bevacizumab | pCR |
NCT02411656 | HER2-negative, metastatic IBC or recurrent disease after treated primary | II | 35 | Adjuvant pembrolizumab for up to 24 months | DCR |
NCT01036087 | HER2-negative, locally advanced IBC | II | 40 | Neoadjuvant panitumumab + nab-paclitaxel + carboplatin + FEC | pCR |
NCT01796197 | Nonmetastatic, HER2-positive IBC | II | 30 | Preoperative trastuzumab + pertuzumab + paclitaxel followed by adjuvant trastuzumab + pertuzumab +/− AC |
pCR |
NCT02041429 | Unresectable or metastatic triple-negative IBC | I/II | 24 | Preoperative ruxolitinib + paclitaxel | MTD |
NCT01525966 | Locally advanced, triple-negative IBC (also open in non-IBC) | II | 69 | Preoperative carboplatin and paclitaxel (albumin-stabilized nanoparticle) |
pCR |