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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]
  1. aCXCR4, C-X-C chemokine receptor type 4; RANKL, receptor activator of nuclear factor-kB ligand; c-Src, proto-oncogene non-receptor tyrosine kinase. bData obtained from ClinicalTrials.gov [56].