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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
38
Udon Thani Cancer Hospital
Udon Thani, Changwat Udon Thani, Thailand
Siriraj Hospital, Mahidol University
Bangkok, Thailand
Lampang Cancer Center
Lampang, Thailand
Ubon Ratchanthani Cancer Hospital
Ubon Ratchathani, Thailand
Change (%) in the sum of diameters of target lesions
Diameter of target lesions will be measured by computer tomography (CT) with contrasting using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: baseline to Day 32 of treatment
Number of target lesions
Number of target lesions per each patient will be evaluated by CT with contrasting. Number of target lesions at baseline and Day 32 of treatment will be presented in shift tables.
Time frame: baseline to Day 32 of treatment
Treatment response
In accordance with RECIST v1.1 the treatment response will be classified as 'complete response', 'partial response', 'stable disease' or 'progressive disease': Complete response (CR): disappearance of all target lesions. Partial response (PR): at least 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of diameters. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum might also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions will also be considered progression. Stable disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: baseline to Day 32 of treatment
Karnofsky Performance Status (KPS) score
KPS describes an outcome in 11 grades, starting as normal without complaints and evidence of disease (equals 100 as the best) and dead (equals 0) as the lowest. KPS score will be assessed every 16 days during 32-day treatment period.
Time frame: baseline to Day 16 and Day 32 of treatment
Separate scores of the general questionnaire EORTC QLQ-C30
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The EORTC QLQ-C30 is a general quality of life questionnaire for cancer patients. The questionnaire contains 30 questions. Three variables will be obtained from the EORTC QLQ-C30: the sum of scores C1 to C5 denoted as "Physical activity problem last week", the sum of scores C6 to C28 denoted as "Discomfort last week", and the sum of scores C29 and C30 denoted as "Health and quality of life".
Time frame: baseline to Day 16 and Day 32 of treatment
Separate scores of the specific questionnaire EORTC QLQ-BR23
The EORTC QLQ-BR23 is a breast cancer-specific quality of life questionnaire. The questionnaire consists of 23 questions. Three variables will be obtained from the EORTC-BR23: the sum of scores BR1 to BR13 denoted as "Breast cancer problem last week", the sum of scores BR14 to BR16 denoted as "Sexual interest and activity last four weeks" and the sum of scores BR17 to BR23 denoted as "Breast cancer related pain and discomfort last week".
Time frame: baseline to Day 16 and Day 32 of treatment
Maximum Common Toxicity Criteria (CTC) score
Maximum CTC score will be recorded using NCI Common Toxicity Criteria v2.0 divided in 15 categories.
Time frame: baseline to Day 16 and Day 32 of treatment
Change in the Sum CTC score
The Sum CTC score will be a sum of all registered CTC scores by 15 categories.
Time frame: baseline to Day 16 and Day 32 of treatment
Number of registered adverse events
Adverse events (AEs) will be coded according to the MedDRA (version 16.1E). AEs will be systemized by system organ class and by preferred term. AEs will be analyzed by severity, seriousness and relatedness to the drug.
Time frame: baseline to Day 32 of treatment