Table 1 Clinical studies of novel bone-targeted therapies in breast cancer
From: Therapeutic targets for bone metastases in breast cancer
Targeta | Agent | Phase | Design, number of patients | Trial numberb and reference |
|---|---|---|---|---|
RANKL | Denosumab | III | Randomized, double-blind, multicenter study of denosumab compared with zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer (n = 2,049) | NCT00321464 [11] |
Denosumab | III | Randomised, double-blind, placebo-controlled, multicenter study to determine the treatment effect of denosumab in subjects with non-metastatic breast cancer receiving aromatase inhibitor therapy (n = 3,400) | NCT00556374 (ongoing) | |
Denosumab | III | Randomised, double-blind, placebo-controlled, multicenter study of denosumab as adjuvant treatment for women with early stage breast cancer at high risk of recurrence (n = 4,500) | NCT01077154 (ongoing) | |
Integrin | Cilengitide | I | Dose escalation study of the safety, tolerability and pharmacokinetic properties of the combination of cilengitide and paclitaxel in patients with advanced solid malignancies (n = 32) | NCT01276496 (ongoing) |
IMGN388 | I | A phase I dose-escalation study of IMGN388 in patients with solid tumors (ovary, lung and breast) that are metastatic or unresectable (n = 90) | NCT00721669 (ongoing) | |
c-Src | Saracatinib | II | A randomised, open-label, pilot study to evaluate the safety and effects on bone resorption of AZD0530 in patients with prostate cancer or breast cancer with bone metastases (n = 132) | NCT00558272 (ongoing) |
Saracatinib | II | A study of AZD0530 in hormone receptor-negative, metastatic or unresectable, locally advanced breast cancer (n = 41) | NCT00559507 (ongoing) | |
Dasatinib | I/II | A study of dasatinib in combination with zoledronic acid for the treatment of breast cancer with bone metastasis (n = 55) | NCT00566618 (ongoing) | |
Dasatinib | II | Studies of two different schedules of dasatinib (NSC-732517) in bone metastasis predominant metastatic breast cancer (n = 80) | NCT00410813 (ongoing) | |
Cathepsin K | Odanacatib | II | A study to assess the safety, tolerability, and efficacy of MK-0822 (cathepsin K inhibitor) in the treatment of women with breast cancer and established bone metastases (n = 45) | NCT00399802 [28] |
CXCR4 | CTCE-9908 | I/II | A study to assess the tolerability and safety profile of repeated administration of CTCE-9908 in patients with advanced metastatic disease (n = 25) who stopped responding to standard treatments or for whom no curative therapy exists (breast cancer, n = 8) | [51] |