Evidence map›Paper›PMID 30721110›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

TBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathologic Complete Response to Pertuzumab and Trastuzumab in Breast Cancer.

Roisin M Connolly, Jeffrey P Leal, Lilja Solnes, Chiung-Yu Huang, Ashley Carpenter, Katy Gaffney, Vandana Abramson, Lisa A Carey, Minetta C Liu, Mothaffar Rimawi and 13 more

Retracted Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRetracted Publication
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It has been retracted, and should not be counted. It is linked to trial NCT01937117 (A Phase 2 Clinical Trial Assessing the Correlation of Early Changes in Standardized Uptake Value), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
4.1field-weighted citation impact, top 5% 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.

NCT01937117 phase2active not recruitingnot on this map

A Phase 2 Clinical Trial Assessing the Correlation of Early Changes in Standardized Uptake Value (SUV) on Positron Emission Tomography (PET) With Pathological Complete Response (pCR) to Pertuzumab and Trastuzumab in Patients With Primary Operable HER2-Positive Breast Cancer

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2014 to 2027Enrolled88ConditionsBreast CancerArmsPositron emission tomography (PET), Trastuzumab, Pertuzumab
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 47 citations in OpenAlex.

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  4. Repeatability ofEJNMMI research · 2024
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  20. Reply to E. Hindié et al.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 11 institutions in 1 country.

Roisin M Connolly1 Johns Hopkins University School of Medicine, Baltimore, MD.
Jeffrey P Leal1 Johns Hopkins University School of Medicine, Baltimore, MD.
Lilja Solnes1 Johns Hopkins University School of Medicine, Baltimore, MD.
Chiung-Yu Huang1 Johns Hopkins University School of Medicine, Baltimore, MD.
Ashley Carpenter1 Johns Hopkins University School of Medicine, Baltimore, MD.
Katy Gaffney1 Johns Hopkins University School of Medicine, Baltimore, MD.
Vandana Abramson2 Vanderbilt University, Nashville, TN.
Lisa A Carey3 University of North Carolina, Chapel Hill, NC.
Minetta C Liu4 Mayo Clinic, Rochester, MN.
Mothaffar Rimawi5 Baylor College of Medicine, Houston, TX.
Jennifer Specht6 University of Washington, Seattle, WA.
Anna Maria Storniolo7 Indiana University, Indianapolis, IN.
Vicente Valero8 The University of Texas MD Anderson Cancer Center, Houston, TX.
Christos Vaklavas9 University of Alabama at Birmingham, Birmingham, AL.
Ian E Krop10 Dana-Farber Cancer Institute, Boston, MA.
Eric P Winer10 Dana-Farber Cancer Institute, Boston, MA.
Melissa Camp1 Johns Hopkins University School of Medicine, Baltimore, MD.
Robert S Miller1 Johns Hopkins University School of Medicine, Baltimore, MD.
Antonio C Wolff1 Johns Hopkins University School of Medicine, Baltimore, MD.
Ashley Cimino-Mathews1 Johns Hopkins University School of Medicine, Baltimore, MD.
Ben H Park1 Johns Hopkins University School of Medicine, Baltimore, MD.
Richard L Wahl1 Johns Hopkins University School of Medicine, Baltimore, MD.
Vered Stearns1 Johns Hopkins University School of Medicine, Baltimore, MD.
Johns Hopkins Medicine · USJohns Hopkins University · USDana-Farber Cancer Institute · USBaylor College of Medicine · USIndiana University – Purdue University Indianapolis · USMayo Clinic in Arizona · USThe University of Texas MD Anderson Cancer Center · USUniversity of Alabama at Birmingham · USUniversity of North Carolina at Chapel Hill · USUniversity of Washington · USVanderbilt University · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
Multi-Modality Quantitiative Imaging for Evaluation of Response to Cancer TherapyU01CA140204 · NCI · JOHNS HOPKINS UNIVERSITY · PI DU, YONG, SOLNES, LILJA · 2011 to 2022
$6.1M
NCI NIH HHS P30 CA006973NCI NIH HHS P30 CA016672NCI NIH HHS U01 CA140204
6 · The paper itself

Abstract

purposePredictive biomarkers to identify patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer who may benefit from targeted therapy alone are required. We hypothesized that early measurements of tumor maximum standardized uptake values corrected for lean body mass (SULmax) on [ PATIENTS AND

methodsPatients with stage II/III, estrogen receptor-negative, HER2-positive breast cancer received four cycles of neoadjuvant PT. [

resultsEighty-eight women were enrolled (83 evaluable), and 85% (75 of 88) completed all four cycles of PT. pCR after PT alone was 34%. Receiver operating characteristic analysis yielded an area under the curve of 0.76 (90% CI, 0.67 to 0.85), which rejected the null hypothesis. Between patients who obtained pCR versus not, a significant difference in median percent reduction in SULmax by C1D15 was observed (63.8% v 33.5%; P < .001), an SULmax reduction greater than or equal to 40% was more prevalent (86% v 46%; P < .001; negative predictive value, 88%; positive predictive value, 49%), and a significant difference in median C1D15 SULmax (1.6 v 3.9; P < .001) and higher proportion of C1D15 SULmax less than or equal to 3 (93% v 38%; P < .001; negative predictive value, 94%; positive predictive value, 55%) were observed.

conclusionEarly changes in SULmax predict response to four cycles of PT in estrogen receptor-negative, HER2-positive breast cancer. Once optimized, this quantitative imaging strategy may facilitate a more tailored approach to therapy in this setting.

Indexed as

Neoadjuvant TherapyAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantErb-b2 Receptor Tyrosine KinasesFemaleFluorodeoxyglucose F18HumansMiddle AgedNeoplasm StagingPredictive Value of TestsRadiopharmaceuticalsAntibodies, Monoclonal, HumanizedERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesFluorodeoxyglucose F18pertuzumabRadiopharmaceuticalsReceptors, EstrogenTrastuzumab

Identifiers

PMID30721110
PMCPMC6424139
OpenAlexW2914243257

What OpenQuestion holds

Textmetadata
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.