BP-C1 in Short-term Treatment of Patients With Metastatic Breast Cancer

Meabco A/S36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Metastatic Breast Cancer Stage IV Breast Cancer

Interventions

BP-C1DRUG

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

PlaceboDRUG

Placebo, solution for injection; doses: 0.07 mL/kg body weight intramuscularly once daily for 32 consecutive days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: Female patients with histologically verified metastatic breast cancer (stage IV) with measurable metastases, between 18 and 80 years of age, who had undergone at least three lines of chemotherapy and had an expected survival time of at least 3 months. Exclusion criteria: Patients fulfilling at least one of the following criteria will be excluded from participation in the study: * Abnormal liver function classified as total bilirubin \>34 μmol/L or ALAT \> 3 times of the upper limit of normal (ULN). In case of metastases in the liver, the ALAT limit for exclusion is set to 5хULN. * Abnormal kidney function defined by serum creatinine \>120 μmol/L. * Abnormal coagulation capacity defined by the relative arbitrary concentration of coagulation factors 2,7,10; INR \>1.5. * Verified metastases to the brain. * Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer. * Abnormal hematology status defined by hemoglobin \< 9.0 g/dL, platelet count \< 100,000/mm\^3 or leucocytes \< 3 x 10\^9/L. * Clinically significant abnormal ECG. * Karnofsky performance status score \<60%. * Pregnant or breast feeding women. * Women of fertile age who do not want to be tested for possible pregnancy. * Fertile female who do not want to use safe protection against pregnancy, starting one month before the start of the study treatment and lasting at least six weeks after. * Uncontrolled bacterial, viral, fungal or parasite infection. * Under systemic treatment with corticosteroids or other immunosuppressive drugs in the last 21 days before start of the trial treatment. * Participating in another clinical trial with pharmaceuticals in the last six weeks before start of this trial treatment. * Not able to understand information. * Not willing or not able to give written consent to participate in the study.

Locations (6)

Russian Oncological Research Centre n.a. N.N. Blokhin, Russian Academy of Medical Science (RAMS)

Moscow, Russia

State Budgetary Institution of Nizhniy Novgorod Region "Oncology Dispensary of Nizhniy Novgorod" (Branch nr.1)

Nizhny Novgorod, Russia

Leningrad Regional Oncological Centre

Saint Petersburg, Russia

St. Petersburg State Budgetary Health Organization, City Clinical Oncology Dispensary

Outcomes

Primary Outcomes

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

Secondary Outcomes

Number of target lesions

Number of target lesions per each patient will be evaluated by CT with contrasting. Change in number of target lesions from baseline to Day 32 of treatment will be presented in shift tables.

Time frame: baseline to Day 32 of treatment

Number of non-target lesions

Number of non-target lesions per each patient will be evaluated by CT with contrasting. Change in number of non-target lesions from baseline to 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.