Evidence map›Paper›PMID 18454159›Full record

Trial reportBritish journal of cancer2008

Bortezomib/docetaxel combination therapy in patients with anthracycline-pretreated advanced/metastatic breast cancer: a phase I/II dose-escalation study.

A Awada, J Albanell, P A Canney, L Y Dirix, T Gil, F Cardoso, P Gascon, M J Piccart, J Baselga

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06900647 (Phase I Study to Evaluate the Safety and Preliminary Efficacy of Bortezomib Combined With Cisplatin in Patients With Recurrent or Metastatic Breast Cancer), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
3.6field-weighted citation impact, top 6% 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.

NCT06900647 phase1recruitingnot on this mapstarted 2025, after this paper: background citation

Phase I Study to Evaluate the Safety and Preliminary Efficacy of Bortezomib Combined With Cisplatin in Patients With Recurrent or Metastatic Breast Cancer

TypeinterventionalSponsorSun Yat-sen UniversityRan2025 to 2028Enrolled20ConditionsMetastatic Breast Cancer, Recurrent Breast CancerArmsBortezomib (B), Cisplatin (CDDP)
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 49 citations in OpenAlex.

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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

9 authors at 5 institutions in 3 countries.

A AwadaMedical Oncology Clinic, Institut Jules Bordet, Brussels, Belgium. ahmad.awada@bordet.be
J Albanell
P A Canney
L Y Dirix
T Gil
F Cardoso
P Gascon
M J Piccart
J Baselga
Institut Jules Bordet · BEConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESBeatson West of Scotland Cancer Centre · GBGZA Ziekenhuizen Campus Sint-Augustinus · BEVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of this study was to determine the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of bortezomib plus docetaxel in patients with anthracycline-pretreated advanced/metastatic breast cancer. Forty-eight patients received up to eight 21-day cycles of docetaxel (60-100 mg m(-2) on day 1) plus bortezomib (1.0-1.5 mg m(-2) on days 1, 4, 8, and 11). Pharmacodynamic and pharmacokinetic analyses were performed in a subset of patients. Five patients experienced DLTs: grade 3 bone pain (n=1) and febrile neutropenia (n=4). The MTD was bortezomib 1.5 mg m(-2) plus docetaxel 75 mg m(-2). All 48 patients were assessable for safety and efficacy. The most common adverse events were diarrhoea, nausea, alopecia, asthenia, and vomiting. The most common grade 3/4 toxicities were neutropenia (44%), and febrile neutropenia and diarrhoea (each 19%). Overall patient response rate was 29%. Median time to progression was 5.4 months. In patients with confirmed response, median time to response was 1.3 months and median duration of response was 3.2 months. At the MTD, response rate was 38%. Pharmacokinetic characteristics of bortezomib/docetaxel were comparable with single-agent data. Addition of docetaxel appeared not to affect bortezomib inhibition of 20S proteasome activity. Mean alpha-1 acid glycoprotein concentrations increased from baseline at nearly all time points across different bortezomib dose levels. Bortezomib plus docetaxel is an active combination for anthracycline-pretreated advanced/metastatic breast cancer. The safety profile is manageable and consistent with the side effects of the individual agents.

Indexed as

AdultAgedAlopeciaAnthracyclinesAntibiotics, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBelgiumBoronic AcidsBortezomibBreast NeoplasmsBreast Neoplasms, MaleDiarrheaDocetaxelDrug Administration ScheduleFemaleHumansAnthracyclinesAntibiotics, AntineoplasticBoronic AcidsBortezomibDocetaxelPyrazinesTaxoids

Identifiers

PMID18454159
PMCPMC2391111
OpenAlexW2076556256

What OpenQuestion holds

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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.