Table 3 Clinical trials of BCSCs-related therapies
From: Heterogeneity of BCSCs contributes to the metastatic organotropism of breast cancer
Modality | Clinical trial | Phase | Study arms | Enrolled population | Patients (n) | Status | Preliminary antitumor efficacy |
|---|---|---|---|---|---|---|---|
Monotherapy | NCT00106145 [77] | I | MK-0752 | adult patients with advanced solid tumors | Total: 103 BC: 24 | Completed | Objective CR: 1 glioma patient SD ≥4 months: 10 glioma patients BC patients: no significant efficacy |
Combination therapy | MK-8669-049 NCT01295632 [78] | I | MK-0752 + Ridaforolimus | advanced solid tumors | Total: 30 BC: 2 | Completed | CR: 1 HNSCC patient PR: 1 HNSCC patient SD ≥6 months: 1 HNSCC patient BC patients: no significant efficacy |
Combination therapy | NCT00645333 [79] | Ib | MK-0752 + Docetaxel | locally advanced or metastatic breast cancer | 30 | Completed | PR: 11 patients SD: 9 patients PD: 3 patients |
Combination therapy | NCT02784795 [80] | Ib | LY3039478 + taladegib LY3039478 + LY3023414 LY3039478 + abemaciclib | advanced or metastatic solid tumors | Total: 63 BC: 12 | Completed | CR/PR: none DCR: Part A: NA, Part B: 18.8 %, Part C: 26.1 % BC patients: no significant efficacy |
Combination therapy | EDALINE NCT02027376 [81] | Ib | sonidegib (LDE225) + docetaxel | triple negative advanced breast cancer | 12 | Completed | Median TTP: 42.5 days (95 % CI: 29-155 days) |
Monotherapy | NCT01351103 [82] | I | WNT974 | advanced solid tumors | Total: 94 BC: 20 | Recruiting | SD: 16 % BC patients: no significant efficacy |
Monotherapy | NCT01861054 [83] | II | Reparixin | operable HER2-negative breast cancer | 20 | Terminated | BCSC markers CD24-/CD44+ and ALDH+: decrease ≥20 % |
Combination therapy | NCT02001974 [84] | Ib | Reparixin + Paclitaxel | HER2-negative metastatic breast cancer | 30 | Completed | RR: 30 % DR >12 months: 2 patients |