BP-C1 in Short-term Treatment of Patients With Metastatic Breast Cancer
Condition: Metastatic Breast Cancer; Stage IV Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether BP-C1 is effective in the treatment of
      metastatic breast cancer patients who had previously received at least three lines of
      chemotherapy.
    

Detailed description: 
      BP-C1, solution for injection 0.05%, is currently being developed for treatment of patients
      with metastatic breast cancer with palliative intent. Active substance of the product, which
      is a novel platinum-containing anticancer agent developed for intramuscular administration,
      is a cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic
      acids derived from lignin. The amphiphilic characteristics of the polymer have resulted in a
      product with clear and significantly altered and improved properties compared to other
      platinum analogues, e.g. cisplatin, carboplatin and oxaliplatin.

      BP-C1 preserves antitumour activity of its predecessors (e.g. cisplatin and carboplatin),
      additionally offering the following advantages that ensure favourable outcome of treatment of
      metastatic breast cancer patients:

        -  injectable solution (intramuscular) does not cause injection site reactions;

        -  can be administered at home by a nurse or a patient;

        -  has an improved pharmacokinetic profile;

        -  demonstrates efficacy comparable to cisplatin and much higher than carboplatin
           (in-vitro; in-vivo data);

        -  exerts an additional immunomodulatory activity.

      This study is a randomised, double-blind, placebo-controlled, multicentre, phase IIb study.
      The eligible patients will be allocated (1:1) to either BP-C1 arm or Placebo arm and treated
      once daily for 32 days. The patients allocated to Placebo arm will cross over to BP-C1
      treatment for 32 days when progression of the cancer will be documented and latest after
      32-day treatment with Placebo. After 32-day treatment with BP-C1 the patients are invited to
      participate in the study BMC2011-02 to continue open-label BP-C1 treatment.
    

Intervention name(s): BP-C1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BP-C1, 0.05% solution for injection; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days; Placebo, solution for injection; doses: 0.07 mL/kg body weight intramuscularly once daily for 32 consecutive days
Other intervention name(s): Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin; Cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BP-C1; Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin; Benzene polycarboxylic acids complex with cis-diammineplatinum(II); Metastatic Breast Cancer; Platinum analogue; Metronomic chemotherapy; Breast cancer; Cisplatin; Cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin