Table 4.
Ongoing studies of eribulin in breast cancer
| Study design | Treatment setting | Treatment arm(s) | Primary objective | Secondary objectives | Start date |
|---|---|---|---|---|---|
| Metastatic breast cancer studies Phase 1 | |||||
| Combination eribulin plus PLX3397 (CSF1 inhibitor) | Pretreated | Dose escalation cohorts of PLX3397 | MTD of PLX3397 percentage of patients without progression | Serum studies, safety assessment, immune response, response rate | July 2012 |
| Combination eribulin plus mifepristone (PR antagonist) in triple negative MBC and ovarian cancer | Pretreated | Dose escalation cohorts of mifepristone + eribulin | MTD | January 2014 | |
| Combination eribulin plus POL6326 (CXCR4 antagonist) in MBC | Pretreated | Dose escalation cohorts of POL6326, eribulin | Safety/tolerability | Response rate | June 2013 |
| Combination eribulin plus carboplatin in MBC | Pretreated | Dose escalation cohorts of eribulin + carboplatin | MTD | Response rate | February 2013 |
| Combination eribulin plus everolimus in triple-negative MBC | Pretreated TNBC | Dose escalation cohorts of eribulin + everolimus | RP2D of combination Event-free survival | Safety, OS | Due October 2014 |
| Phase II | |||||
| Combination eribulin, trastuzumab and pertuzumab in HER2-positive MBC | Second line HER2 positive | Eribulin + trastuzumab + pertuzumab | Safety/tolerability Response rate | PFS, OS | August 2013 |
| Efficacy and tolerability of eribulin plus lapatinib in patients with metastatic breast cancer (E-VITA) | Second-line HER2-positive | Lapatinib + eribulin (two dose schedules of eribulin) | TTP Safety/toxicity | ORR, CBR, OS, biomarker analysis | February 2012 |
| Metronomic eribulin in MBC after chemotherapy | Pretreated | Eribulin | PFS | Safety | January 2014 |
| Combination eribulin plus bevacizumab in HER2-negative MBC | First-line HER2-negative | Eribulin + bevacizumab | Disease control rate | Toxicity | November 2013 |
| First-line eribulin in HER2-negative MBC | First-line HER2-negative | Eribulin | TTP | Response rate, CBR, duration of response, safety | June 2013 |
| Eribulin plus gemcitabine versus paclitaxel plus gemcitabine in HER2-negative metastatic breast cancer | First-line HER2-negative | a) Paclitaxel + gemcitabine b) Eribulin + gemcitabine |
PFS | OS, neurotoxicity, toxicity, DOR, ORR, CBR | October 2014 |
| First/second-line eribulin in HER2-negative MBC | First/second-line HER2-negative | Eribulin | Response rate | PFS, DOR, safety, neurotoxicity/QOL assessment | June 2013 |
| Combination eribulin plus bevacizumab in MBC | Second-line HER2-negative | Eribulin + bevacizumab | Response rate | PFS, OS, CBR, DOR, safety, QOL | Due September 2014 |
| Trastuzumab plus pertuzumab alone or combined with hormonal therapy or eribulin in patients over 60 years of age with HER2-positive MBC | First/second-line HER2-positive | a) Trastuzumab + pertuzumab b) Trastuzumab + pertuzumab + hormonal therapy c) Trastuzumab + pertuzumab + eribulin |
Response rate | December 2013 | |
| Phase III | |||||
| Paclitaxel versus eribulin in HER2-negative MBC | First/second-line HER2-negative | a) Paclitaxel b) Eribulin |
OS | Response rate, DOR, TTF, toxicity, PFS | January 2014 |
| Early-stage breast cancer studies Phase II | |||||
| Pharmacogenomic study of neoadjuvant eribulin in HER2-negative BC | Neoadjuvant HER2-negative | Eribulin | mRNA correlation with pCRB rate | pCR rate, safety, gene expression prediction | August 2012 |
| Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide in HER2-negative LABC | Neoadjuvant HER2-negative | Eribulin followed by doxorubicin + cyclophosphamide | pCR rate | Toxicity | November 2011 |
| Neoadjuvant eribulin followed by FAC versus paclitaxel followed by FEC in HER2-negative BC | Neoadjuvant HER2-negative | a) Eribulin followed by FEC/FAC b) Paclitaxel followed by FEC/FAC |
pCR rate | August 2012 | |
| Eribulin in combination with capecitabine for adjuvant treatment in estrogen receptor-positive early-stage breast cancer | Adjuvant ER-positive HER2-negative | Eribulin + capecitabine | Feasibility/safety (RDI) | Toxicity | August 2011 |
Abbreviations: MTD, maximum tolerated dose; RP2D, recommended Phase II dose; OS, overall survival; TNBC, triple-negative breast cancer; HER2, human epidermal growth factor receptor 2; MBC, metastatic breast cancer; PFS, progression-free survival; TTP, time to progression; CBR, clinical benefit rate; DOR, duration of response; QOL, quality of life; TTF, time-to-treatment failure; BC, breast cancer; pCR, pathological complete response; 5-FU, 5-fluorouracil; PR, progesterone receptor; RDI, relative dose intensity; FEC, 5-Fluorouracil, Epirubicin, Cyclophosphamide; FAC, 5-Fluorouracil, Doxorubicin, Cyclophosphamide; pCRB, pathological complete response in breast.