Table 6.
Ongoing clinical studies investigating eribulin in patients with breast cancer
| Study design | Treatments | Study identifier | |||
|---|---|---|---|---|---|
| Regimen setting | Disease type | Trial details (estimated enrolment) | Primary endpoint | ||
| Non-metastatic disease | |||||
| Neo-adjuvant | HER2+ | Phase I/II, OL, SG (56) | pCR | Eribulin + carboplatin, trastuzumab | NCT01388647 [34] |
| HER2− | Phase II, OL, SG (47) | pCR | Eribulin then dose-dense doxorubicin + cyclophosphamide | NCT01498588 [35] | |
| HER2− | Phase II, R, PG, OL (152) | pCR | Eribulin then FAC vs paclitaxel then FEC | NCT01593020 [36] | |
| HER2− | Phase II, R, PG, OL (76) | pCR | Eribulin + cyclophosphamide vs docetaxel + cyclophosphamide | NCT01527487 [37] | |
| TN | Phase II, SG, OL (30) | pCR | Eribulin + carboplatin | NCT01372579 [38] | |
| Adjuvant | TN, HER2+, HER2− | Phase II, PG, OL (148) | 2-year DFS | Eribulin or eribulin + trastuzumab in patients who do not achieve pCR following neo-adjuvant chemotherapy | NCT01401959 [39] |
| ER+ | Phase II, SG, OL (67) | Feasibility | Eribulin + capecitabine | NCT01439282 [40] | |
| NS | Phase II, SG, OL (80) | Feasibility | Dose-dense doxorubicin + cyclophosphamide then eribulin | NCT01328249 [41] | |
| Metastatic disease | |||||
| First-line | HER2+ | Phase II, SG, OL (52) | ORR | Eribulin + trastuzumab | NCT01269346 [42] |
| First-line | HER2− | Phase II, SG, OL (52) | ORR | Eribulin | NCT01268150 [44] |
| Second-line | HER2− | Phase II, R, PG, OL (141) | PFS | Eribulin +/− ramucirumab | NCT01427933 [45] |
| Second-line | TN | Phase I/II SG, OL (80) | MTD, PFS | Eribulin + PLX 3397 | NCT01596751 [46] |
| Fourth-line | NS | Phase I/II, R, OL (116) | Tolerability, response | Eribulin + capecitabine | NCT01323530 [47] |
| NS | HER2+ | Phase II, R, PG, OL (80) | TTP, tolerability | Eribulin + lapatinib | NCT01534455 [43] |
| NS | NS | Phase I/II, SG, OL (58) | MTD, CBR | Eribulin + cyclophosphamide | NCT01554371 [48] |
| NS | NS | Phase I, SG, OL (54) | Tolerability, AUC, C max, QT time | Eribulin + sorafenib | NCT01585870 [49] |
AUC area under the drug concentration–time curve, CBR clinical benefit rate, C max peak drug concentration, DFS disease-free survival, ER oestrogen receptor, FAC fluorouracil + doxorubicin + cyclophosphamide, FEC fluorouracil + epirubicin + cyclophosphamide, HER2 human epidermal growth factor receptor 2, MTD maximum tolerated dose, NS not specified, OL open label, ORR objective response rate, pCR pathological complete response rate, PFS progression-free survival, PG parallel group, R randomized, SG single group, TN triple negative, TTP time to progression