NCT02783794

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_2

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 24, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

May 18, 2016

Last Update Submit

October 8, 2019

Conditions

Metastatic Breast CancerStage IV Breast Cancer

Keywords

BP-C1Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from ligninBenzene polycarboxylic acids complex with cis-diammineplatinum(II)Metastatic Breast CancerPlatinum analogueMetronomic chemotherapyBreast cancerCisplatinCis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline to Day 32 of treatment

Secondary Outcomes (9)

  • Number of target lesions

    baseline to Day 32 of treatment

  • Number of non-target lesions

    baseline to Day 32 of treatment

  • Treatment response

    baseline to Day 32 of treatment

  • Karnofsky Performance Status (KPS) score

    baseline to Day 16 and Day 32 of treatment

  • Changes in the scores of the general questionnaire EORTC QLQ-C30 ("Physical activity problem last week", "Discomfort last week", "Health and quality of life")

    baseline to Day 16 and Day 32 of treatment

  • +4 more secondary outcomes

Study Arms (2)

BP-C1

EXPERIMENTAL

Patients randomized to BP-C1 arm will be treated for 32 consecutive days. Patients who respond to treatment and do not experience untolerated toxicity are invited to participate in the BMC2011-02 study, where they will be offered to continue treatment with BP-C1.

Drug: BP-C1

Placebo

PLACEBO COMPARATOR

Patients randomized to Placebo arm will be treated for 32 consecutive days. Thereafter the patients will cross over to 32-day treatment with BP-C1. Patients who respond to treatment and do not experience untolerated toxicity are invited to participate in the BMC2011-02 study, where they will be offered to continue treatment with BP-C1.

Drug: Placebo

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

Also known as: 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
BP-C1
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients fulfilling at least one of the following criteria will be excluded from participation in the study:
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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

Moscow, Russia

Location

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

Nizhny Novgorod, Russia

Location

Leningrad Regional Oncological Centre

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

Siriraj Hospital, Mahidol University

Bangkok, Thailand

Location

Udon Thani Cancer Hospital

Udon Thani, Thailand

Location

Related Publications (2)

  • Larsen S, Butthongkomvong K, Manikhas A, Trishkina E, Poddubuskaya E, Matrosova M, Srimuninnimit V, Lindkaer-Jensen S. BP-C1 in the treatment of patients with stage IV breast cancer: a randomized, double-blind, placebo-controlled multicenter study and an additional open-label treatment phase. Breast Cancer (Dove Med Press). 2014 Nov 27;6:179-89. doi: 10.2147/BCTT.S71781. eCollection 2014.

    PMID: 25473312RESULT

  • Erratum: BP-C1 in the treatment of patients with stage IV breast cancer: a randomized, double-blind, placebo-controlled multicenter study and an additional open-label treatment phase [Corrigendum]. Breast Cancer (Dove Med Press). 2015 Jun 29;7:163. doi: 10.2147/BCTT.S84920. eCollection 2015.

    PMID: 26170717RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Steen Lindkær-Jensen, MD

    Meabco A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 26, 2016

Study Start

December 24, 2012

Primary Completion

February 28, 2014

Study Completion

February 28, 2014

Last Updated

October 10, 2019

Record last verified: 2019-10

Locations

TH(2)RU(4)