Evidence map›Paper›PMID 38297352›Full record

Trial reportBreast cancer research : BCR2024

TBCRC 039: a phase II study of preoperative ruxolitinib with or without paclitaxel for triple-negative inflammatory breast cancer.

Filipa Lynce, Laura E Stevens, Zheqi Li, Jane E Brock, Anushree Gulvady, Ying Huang, Faina Nakhlis, Ashka Patel, Jeremy M Force, Tufia C Haddad and 19 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research : BCR, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02876302 (Phase II Study Of Combination Ruxolitinib), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
5.1field-weighted citation impact, top 4% 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.

NCT02876302 phase2completednot on this map

Phase II Study Of Combination Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer

TypeinterventionalSponsorDana-Farber Cancer InstituteRan2018 to 2024Enrolled23ConditionsInflammatory Breast Cancer (IBC)ArmsRuxolitinib, Paclitaxel, Doxorubicin, Cyclophosphamide
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 18 citations in OpenAlex.

  1. Review
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  10. Protein Marker-Dependent Drug Discovery Targeting Breast Cancer Stem Cells.International journal of molecular sciences · 2025
    Review
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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

29 authors at 12 institutions in 1 country.

Filipa Lynce *Dana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA. Filipa_Lynce@dfci.harvard.edu.
Laura E Stevens *Dana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA.
Zheqi LiDana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA.
Jane E BrockHarvard Medical School, Boston, MA, USA.
Anushree GulvadyDana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA.
Ying HuangDana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA.
Faina NakhlisDana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA.
Ashka PatelDana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA.
Jeremy M ForceDuke University, Durham, NC, USA.
Tufia C HaddadMayo Clinic, Rochester, MN, USA.
Naoto UenoMD Anderson Cancer Center, Houston, TX, USA.
Vered StearnsJohns Hopkins University, Baltimore, MA, USA.
Antonio C WolffJohns Hopkins University, Baltimore, MA, USA.
Amy S ClarkUniversity of Pennsylvania, Philadelphia, PA, USA.
Jennifer R BellonDana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA.
Edward T RichardsonHarvard Medical School, Boston, MA, USA.
Justin M BalkoVanderbilt University Medical Center, Nashville, TN, USA.
Ian E KropDana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA.
Eric P WinerDana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA.
Paulina LangeDana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA.
E Shelley HwangDuke University, Durham, NC, USA.
Tari A KingDana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA.
Sara M TolaneyDana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA.
Alastair ThompsonBaylor College of Medicine, Houston, TX, USA.
Gaorav P GuptaUniversity of North Carolina, Chapel Hill, NC, USA.
Elizabeth A MittendorfDana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA.
Meredith M ReganDana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA.
Beth Overmoyer *Dana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA.
Kornelia Polyak *Dana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA. kornelia_polyak@dfci.harvard.edu.
Dana-Farber Cancer Institute · USHarvard University · USBrigham and Women's Hospital · USDuke University · USJohns Hopkins University · USBaylor College of Medicine · USDana-Farber/Harvard Cancer Center · USMayo Clinic in Arizona · USThe University of Texas MD Anderson Cancer Center · USUniversity of North Carolina at Chapel Hill · USUniversity of Pennsylvania · USVanderbilt University Medical Center · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Targeting intratumor heterogeneity in breast cancerR35CA197623 · NCI · DANA-FARBER CANCER INST · PI KORNELIA POLYAK · 2015 to 2026
$12.4M
Cancer Chemical Biology and Metabolism Training ProgramT32CA236754 · NCI · DANA-FARBER CANCER INST · PI Nika N Danial, THOMAS M ROBERTS · 2019 to 2026
$2.6M
NCATS NIH HHS UL1 TR001863NCI NIH HHS R35 CA197623NCI NIH HHS T32 CA236754
6 · The paper itself

Abstract

backgroundPatients with inflammatory breast cancer (IBC) have overall poor clinical outcomes, with triple-negative IBC (TN-IBC) being associated with the worst survival, warranting the investigation of novel therapies. Preclinical studies implied that ruxolitinib (RUX), a JAK1/2 inhibitor, may be an effective therapy for TN-IBC.

methodsWe conducted a randomized phase II study with nested window-of-opportunity in TN-IBC. Treatment-naïve patients received a 7-day run-in of RUX alone or RUX plus paclitaxel (PAC). After the run-in, those who received RUX alone proceeded to neoadjuvant therapy with either RUX + PAC or PAC alone for 12 weeks; those who had received RUX + PAC continued treatment for 12 weeks. All patients subsequently received 4 cycles of doxorubicin plus cyclophosphamide prior to surgery. Research tumor biopsies were performed at baseline (pre-run-in) and after run-in therapy. Tumors were evaluated for phosphorylated STAT3 (pSTAT3) by immunostaining, and a subset was also analyzed by RNA-seq. The primary endpoint was the percent of pSTAT3-positive pre-run-in tumors that became pSTAT3-negative. Secondary endpoints included pathologic complete response (pCR).

resultsOverall, 23 patients were enrolled, of whom 21 completed preoperative therapy. Two patients achieved pCR (8.7%). pSTAT3 and IL-6/JAK/STAT3 signaling decreased in post-run-in biopsies of RUX-treated samples, while sustained treatment with RUX + PAC upregulated IL-6/JAK/STAT3 signaling compared to RUX alone. Both treatments decreased GZMB

conclusionIn summary, the use of RUX in TN-IBC was associated with a decrease in pSTAT3 levels despite lack of clinical benefit. Cancer cell-specific-targeting of JAK2/STAT3 or combinations with immunotherapy may be required for further evaluation of JAK2/STAT3 signaling as a cancer therapeutic target.

trial registrationwww. CLINICALTRIALS: gov , NCT02876302. Registered 23 August 2016.

Indexed as

Inflammatory Breast NeoplasmsNitrilesPaclitaxelPyrazolesPyrimidinesTriple Negative Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansInterleukin-6Neoadjuvant TherapyTreatment OutcomeInterleukin-6NitrilesPaclitaxelPyrazolesPyrimidinesruxolitinibInflammatory breast cancerNeoadjuvantPaclitaxelRuxolitinibTriple negative

Identifiers

PMID38297352
PMCPMC10829369
OpenAlexW4391401710

What OpenQuestion holds

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LicenceCC BY
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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.