Evidence map›Paper›PMID 30666153›Full record

ArticleBreast cancer (Dove Medical Press)2019

Efficacy and tolerability of BP-C1 in metastatic breast cancer: a Phase II, randomized, double-blind, and placebo-controlled Thai multi-center study.

Kritiya Butthongkomvong, Nilubol Raunroadroong, Sirikul Sorrarichingchai, Isaraporn Sangsaikae, Vichien Srimuninnimit, Henrik Harling, Stig Larsen

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Breast cancer (Dove Medical Press), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03603197 (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), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03603197 phase2completednot on this map

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

TypeinterventionalSponsorMeabco A/SRan2014 to 2016Enrolled38ConditionsMetastatic Breast Cancer, Stage IV Breast CancerArmsBP-C1, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 7 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 6 institutions in 3 countries.

Kritiya ButthongkomvongUdonthani Cancer Hospital, Udonthani, Thailand.
Nilubol RaunroadroongLampang Cancer Hospital, Lampang, Thailand.
Sirikul SorrarichingchaiLampang Cancer Hospital, Lampang, Thailand.
Isaraporn SangsaikaeUbonratchathani Cancer Hospital, Ubonratchathani, Thailand.
Vichien SrimuninnimitDivision of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Henrik HarlingBispebjerg University Hospital, Department of Gastroenterology, Center for Digestive Disease, Copenhagen, Denmark.
Stig LarsenDigestive Disease Center, Centre for Epidemiology and Biostatistics, Norwegian University of Life Sciences, Oslo, Norway, stig.larsen@nmbu.no.
Lampang Cancer Hospital · THBispebjerg Hospital · DKNorwegian University of Life Sciences · NOSiriraj Hospital · THSuratthani Cancer Hospital · THUbonratchathani Cancer Hospital · TH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe aim of this study was to compare the efficacy and tolerability of BP-C1 vs equal-looking placebo in metastatic breast cancer. MATERIALS AND

methodsA randomized, double-blind, placebo-controlled multi-center study with a semicross-over design was performed. Sixteen patients received daily intramuscular injection of 0.035 mg/kg bodyweight of BP-C1 and 15 patients received equal-looking placebo for 32 days. After 32 days, the placebo patients crossed to BP-C1 with the last observation in the placebo period as baseline. The status of receptors including estrogen receptor (ER), progesterone receptor (PtR), and human EGF receptor 2 (HER2) was analyzed prior to inclusion in the study. Thoracoabdominal CT scan was blindly analyzed by the same independent radiologist in accordance with the RECIST criteria 1.1. Toxicity was assessed according to the NCI Bethesda Version 2.0 (CTC-NCI), and the quality of life (QOL) was assessed according to European Organization for the Research and Treatment of Cancer QOL-C30 and QOL-BR23.

resultsThe sum of target lesion diameters (sum lesions) after 32 days of treatment increased by 8.9% (

conclusionA total of 32 days of BP-C1 treatment inhibited cancer growth and was well tolerated with few and mainly mild AEs. The efficacy of BP-C1 was superior in receptor-negative patients. CLINICALTRIALSGOV IDENTIFIER: NCT03603197.

Indexed as

benzene-polycarboxylic acid complexBP-C1breast cancerhormone receptorslow-dose cisplatinrandomized double-blindstage IV

Identifiers

PMID30666153
PMCPMC6336026
OpenAlexW2909028282

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.