Evidence map›Paper›PMID 28918548›Full record

Trial reportBreast cancer research and treatment2018

Tumor and serum DNA methylation in women receiving preoperative chemotherapy with or without vorinostat in TBCRC008.

Roisin M Connolly, Mary Jo Fackler, Zhe Zhang, Xian C Zhou, Matthew P Goetz, Judy C Boughey, Bridget Walsh, John T Carpenter, Anna Maria Storniolo, Stanley P Watkins and 3 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00616967 (A Multi-Institutional Double-Blind Phase II Study Evaluating Response and Surrogate Biomarkers to Carboplatin and Nab-Paclitaxel), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
0.4field-weighted citation impact, top 36% 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.

NCT00616967 phase2active not recruitingnot on this map

A Multi-Institutional Double-Blind Phase II Study Evaluating Response and Surrogate Biomarkers to Carboplatin and Nab-Paclitaxel (CP) With or Without Vorinostat as Preoperative Chemotherapy in HER2-negative Primary Operable Breast Cancer

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2008 to 2027Enrolled68ConditionsBreast CancerArmscarboplatin, paclitaxel albumin-stabilized nanoparticle formulation, vorinostat, placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 17 citations in OpenAlex.

  1. Article
  2. Review
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  6. Gain of Function (GOF) Mutant p53 in Cancer-Current Therapeutic Approaches.International journal of molecular sciences · 2022
    Review
  7. Review
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  9. Article
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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

13 authors at 6 institutions in 1 country.

Roisin M ConnollySidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, 1650 Orleans St., Baltimore, MD, 21287, USA.
Mary Jo FacklerSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, 1650 Orleans St., Baltimore, MD, 21287, USA.
Zhe ZhangSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, 1650 Orleans St., Baltimore, MD, 21287, USA.
Xian C ZhouSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, 1650 Orleans St., Baltimore, MD, 21287, USA.
Matthew P GoetzMayo Clinic, 200 First St. SW, Rochester, MN, 55905, USA.
Judy C BougheyMayo Clinic, 200 First St. SW, Rochester, MN, 55905, USA.
Bridget WalshSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, 1650 Orleans St., Baltimore, MD, 21287, USA.
John T CarpenterUniversity of Alabama at Birmingham, 1720 2nd Avenue South, Birmingham, AL, 35294, USA.
Anna Maria StornioloIndiana University, 1030 W. Michigan St., Indianapolis, IN, 46202, USA.
Stanley P WatkinsAnne Arundel Medical Center, 2003 Medical Parkway, Annapolis, MD, 21401, USA.
Edward W GabrielsonSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, 1650 Orleans St., Baltimore, MD, 21287, USA.
Vered StearnsSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, 1650 Orleans St., Baltimore, MD, 21287, USA. vstearn1@jhmi.edu.
Saraswati SukumarSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, 1650 Orleans St., Baltimore, MD, 21287, USA. saras@jhmi.edu.
Johns Hopkins University · USSidney Kimmel Comprehensive Cancer Center · USMayo Clinic · USAnne Arundel Medical Center · USIndiana University – Purdue University Indianapolis · USUniversity of Alabama at Birmingham · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
VACCINES--A NEW PARADIGM FOR BREAST CANCERP50CA088843 · NCI · JOHNS HOPKINS UNIVERSITY · PI DAVIDSON, NANCY ELLEN · 2000 to 2010
$27.8M
Abraxis drug supplyAvon Foundation for Women 02-2010-048Breast Cancer Research Foundation 316-2016Cindy Rosencrans fund for TNBC 80022485Merck drug supplyNCI NIH HHS P30 CA006973NCI NIH HHS P50 CA088843NIH HHS P30 CA006973NIH HHS P50 CA88843Susan G. Komen LRTSTBCR07
6 · The paper itself

Abstract

backgroundMethylated gene markers have shown promise in predicting breast cancer outcomes and treatment response. We evaluated whether baseline and changes in tissue and serum methylation levels would predict pathological complete response (pCR) in patients with HER2-negative early breast cancer undergoing preoperative chemotherapy.

methodsThe TBCRC008 trial investigated pCR following 12 weeks of preoperative carboplatin and albumin-bound paclitaxel + vorinostat/placebo (n = 62). We measured methylation of a 10-gene panel by quantitative multiplex methylation-specific polymerase chain reaction and expressed results as cumulative methylation index (CMI). We evaluated association between CMI level [baseline, day 15 (D15), and change] and pCR using univariate and multivariable logistic regression models controlling for treatment and hormone receptor (HR) status, and performed exploratory subgroup analyses.

resultsIn univariate analysis, one log unit increase in tissue CMI levels at D15 was associated with 40% lower chance of obtaining pCR (odds ratio, OR 0.60, 95% CI 0.37-0.97; p = 0.037). Subgroup analyses suggested a significant association between tissue D15 CMI levels and pCR in vorinostat-treated [OR 0.44 (0.20, 0.93), p = 0.03], but not placebo-treated patients.

conclusionIn this study investigating the predictive roles of tissue and serum CMI levels in patients with early breast cancer for the first time, we demonstrate that high D15 tissue CMI levels may predict poor response. Larger studies and improved analytical procedures to detect methylated gene markers in early stage breast cancer are needed. TBCRC008 is registered on ClinicalTrials.gov (NCT00616967).

Indexed as

AdultAgedBiomarkers, TumorBreast NeoplasmsDNA MethylationDNA, NeoplasmFemaleGene Expression Regulation, NeoplasticHumansHydroxamic AcidsMiddle AgedNeoplasm ProteinsPaclitaxelPreoperative PeriodVorinostatBiomarkers, TumorDNA, NeoplasmHydroxamic AcidsNeoplasm ProteinsPaclitaxelVorinostatBiomarkersBreast cancercMethDNAMethylationPreoperative chemotherapy

Identifiers

PMID28918548
PMCPMC5793219
OpenAlexW2754379273

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.