BP-C1 Monotherapy in Patients With Metastatic Breast Cancer Cancer: Estimation of Optimal Duration of Treatment
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 establish an optimal treatment duration and tolerable
      cumulative dose for BP-C1 in the treatment of metastatic breast cancer patients who had
      previously undergone 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 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 an open-label, non-randomised, single-group, multi-centre study with a
      sequential safety design. The study consists of two parts: dose-response part and follow-up
      study.

      Dose-response part: Patients who have completed the first 32-day treatment period with BP-C1
      from Day 1 to Day 32 under Protocol BMC2011-1/Protocol MBC-BPC1/IIB or Protocol BMC2012-4,
      and having a maximum of "moderate" toxicity at the end of treatment are offered to continue
      in the second 32-day treatment period with BP-C1 from Day 33 to Day 64 under protocol
      BMC2011-02. Patients completing 64-day treatment period with BP-C1 will be followed up for 28
      days.

      Follow-up study: After 28-day follow-up period the patients without disease progression and
      without an increase in toxicity are offered to participate in the follow-up study. During the
      follow-up study the patients will be given BP-C1 as long as they obtain benefit from the
      treatment (i.e. until disease progression or increase in toxicity not above "moderate"
      grade).
    

Intervention name(s): BP-C1
Intervention type(s): 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
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
Intervention model: Single Group Assignment
Masking: None (Open Label)
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