Metastatic Breast Cancer Clinical Trial
Official title:
A Randomized, Double Blind and Placebo Controlled Multicenter Study Comparing BP-C1 and an Equal Looking Placebo in Metastatic Breast Cancer Patients. A Phase IIB Study
The purpose of this study is to determine whether BP-C1 is effective in the short-term treatment of metastatic breast cancer patients who have previously undergone at least three lines of chemotherapy.
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 а 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 in
Thai patients with metastatic breast cancer. 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 continue open-label treatment under protocol
BMC2011-02.
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