Evidence map›Paper›PMID 26056183›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2015

Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance).

Hope S Rugo, William T Barry, Alvaro Moreno-Aspitia, Alan P Lyss, Constance Cirrincione, Eleanor Leung, Erica L Mayer, Michael Naughton, Deborah Toppmeyer, Lisa A Carey and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
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, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04248998 (Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemotherapy and a Diet Mimicking FASTing Plus/Minus Metformin in the Preoperative Setting), which is not on this map. Cited by 125 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
125citing papers in PubMed, 13 pooled it
12.1field-weighted citation impact, top 1% 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.

NCT04248998 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemotherapy and a Diet Mimicking FASTing Plus/Minus Metformin in the Preoperative Setting: the BREAKFAST Trial

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2020 to 2024Enrolled30ConditionsTriple-negative Breast CancerArmsFasting-mimicking diet, Metformin, Preoperative chemotherapy
3 · Its place in the literature

Who cites it

125 citing papers in PubMed, 13 syntheses or guidelines pooled it, 226 citations in OpenAlex.

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65 more citing papers are in PubMed but not listed here.

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 1 institution in 1 country.

Hope S RugoHope S. Rugo, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; William T. Barry, Alliance Statistics and Data Center, Dana-Farber Cancer Institute; Erica L. Mayer and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Alvaro Moreno-Aspitia and Edith A. Perez, Mayo Clinic, Jacksonville, FL; Alan P. Lyss, Heartland Cancer Research Community Clinical Oncology Program; Michael Naughton, Washington University School of Medicine, St Louis, MO; Constance Cirrincione and Eleanor Leung, Alliance Statistics and Data Center, Duke University, Durham; Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Deborah Toppmeyer, Cancer Institute of New Jersey, New Brunswick, NJ; and Clifford Hudis, Memorial Sloan Kettering Cancer Center, New York, NY. hrugo@medicine.ucsf.edu.
William T BarryHope S. Rugo, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; William T. Barry, Alliance Statistics and Data Center, Dana-Farber Cancer Institute; Erica L. Mayer and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Alvaro Moreno-Aspitia and Edith A. Perez, Mayo Clinic, Jacksonville, FL; Alan P. Lyss, Heartland Cancer Research Community Clinical Oncology Program; Michael Naughton, Washington University School of Medicine, St Louis, MO; Constance Cirrincione and Eleanor Leung, Alliance Statistics and Data Center, Duke University, Durham; Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Deborah Toppmeyer, Cancer Institute of New Jersey, New Brunswick, NJ; and Clifford Hudis, Memorial Sloan Kettering Cancer Center, New York, NY.
Alvaro Moreno-AspitiaHope S. Rugo, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; William T. Barry, Alliance Statistics and Data Center, Dana-Farber Cancer Institute; Erica L. Mayer and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Alvaro Moreno-Aspitia and Edith A. Perez, Mayo Clinic, Jacksonville, FL; Alan P. Lyss, Heartland Cancer Research Community Clinical Oncology Program; Michael Naughton, Washington University School of Medicine, St Louis, MO; Constance Cirrincione and Eleanor Leung, Alliance Statistics and Data Center, Duke University, Durham; Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Deborah Toppmeyer, Cancer Institute of New Jersey, New Brunswick, NJ; and Clifford Hudis, Memorial Sloan Kettering Cancer Center, New York, NY.
Alan P LyssHope S. Rugo, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; William T. Barry, Alliance Statistics and Data Center, Dana-Farber Cancer Institute; Erica L. Mayer and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Alvaro Moreno-Aspitia and Edith A. Perez, Mayo Clinic, Jacksonville, FL; Alan P. Lyss, Heartland Cancer Research Community Clinical Oncology Program; Michael Naughton, Washington University School of Medicine, St Louis, MO; Constance Cirrincione and Eleanor Leung, Alliance Statistics and Data Center, Duke University, Durham; Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Deborah Toppmeyer, Cancer Institute of New Jersey, New Brunswick, NJ; and Clifford Hudis, Memorial Sloan Kettering Cancer Center, New York, NY.
Constance CirrincioneHope S. Rugo, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; William T. Barry, Alliance Statistics and Data Center, Dana-Farber Cancer Institute; Erica L. Mayer and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Alvaro Moreno-Aspitia and Edith A. Perez, Mayo Clinic, Jacksonville, FL; Alan P. Lyss, Heartland Cancer Research Community Clinical Oncology Program; Michael Naughton, Washington University School of Medicine, St Louis, MO; Constance Cirrincione and Eleanor Leung, Alliance Statistics and Data Center, Duke University, Durham; Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Deborah Toppmeyer, Cancer Institute of New Jersey, New Brunswick, NJ; and Clifford Hudis, Memorial Sloan Kettering Cancer Center, New York, NY.
Eleanor LeungHope S. Rugo, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; William T. Barry, Alliance Statistics and Data Center, Dana-Farber Cancer Institute; Erica L. Mayer and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Alvaro Moreno-Aspitia and Edith A. Perez, Mayo Clinic, Jacksonville, FL; Alan P. Lyss, Heartland Cancer Research Community Clinical Oncology Program; Michael Naughton, Washington University School of Medicine, St Louis, MO; Constance Cirrincione and Eleanor Leung, Alliance Statistics and Data Center, Duke University, Durham; Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Deborah Toppmeyer, Cancer Institute of New Jersey, New Brunswick, NJ; and Clifford Hudis, Memorial Sloan Kettering Cancer Center, New York, NY.
Erica L MayerHope S. Rugo, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; William T. Barry, Alliance Statistics and Data Center, Dana-Farber Cancer Institute; Erica L. Mayer and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Alvaro Moreno-Aspitia and Edith A. Perez, Mayo Clinic, Jacksonville, FL; Alan P. Lyss, Heartland Cancer Research Community Clinical Oncology Program; Michael Naughton, Washington University School of Medicine, St Louis, MO; Constance Cirrincione and Eleanor Leung, Alliance Statistics and Data Center, Duke University, Durham; Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Deborah Toppmeyer, Cancer Institute of New Jersey, New Brunswick, NJ; and Clifford Hudis, Memorial Sloan Kettering Cancer Center, New York, NY.
Michael NaughtonHope S. Rugo, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; William T. Barry, Alliance Statistics and Data Center, Dana-Farber Cancer Institute; Erica L. Mayer and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Alvaro Moreno-Aspitia and Edith A. Perez, Mayo Clinic, Jacksonville, FL; Alan P. Lyss, Heartland Cancer Research Community Clinical Oncology Program; Michael Naughton, Washington University School of Medicine, St Louis, MO; Constance Cirrincione and Eleanor Leung, Alliance Statistics and Data Center, Duke University, Durham; Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Deborah Toppmeyer, Cancer Institute of New Jersey, New Brunswick, NJ; and Clifford Hudis, Memorial Sloan Kettering Cancer Center, New York, NY.
Deborah ToppmeyerHope S. Rugo, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; William T. Barry, Alliance Statistics and Data Center, Dana-Farber Cancer Institute; Erica L. Mayer and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Alvaro Moreno-Aspitia and Edith A. Perez, Mayo Clinic, Jacksonville, FL; Alan P. Lyss, Heartland Cancer Research Community Clinical Oncology Program; Michael Naughton, Washington University School of Medicine, St Louis, MO; Constance Cirrincione and Eleanor Leung, Alliance Statistics and Data Center, Duke University, Durham; Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Deborah Toppmeyer, Cancer Institute of New Jersey, New Brunswick, NJ; and Clifford Hudis, Memorial Sloan Kettering Cancer Center, New York, NY.
Lisa A CareyHope S. Rugo, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; William T. Barry, Alliance Statistics and Data Center, Dana-Farber Cancer Institute; Erica L. Mayer and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Alvaro Moreno-Aspitia and Edith A. Perez, Mayo Clinic, Jacksonville, FL; Alan P. Lyss, Heartland Cancer Research Community Clinical Oncology Program; Michael Naughton, Washington University School of Medicine, St Louis, MO; Constance Cirrincione and Eleanor Leung, Alliance Statistics and Data Center, Duke University, Durham; Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Deborah Toppmeyer, Cancer Institute of New Jersey, New Brunswick, NJ; and Clifford Hudis, Memorial Sloan Kettering Cancer Center, New York, NY.
Edith A PerezHope S. Rugo, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; William T. Barry, Alliance Statistics and Data Center, Dana-Farber Cancer Institute; Erica L. Mayer and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Alvaro Moreno-Aspitia and Edith A. Perez, Mayo Clinic, Jacksonville, FL; Alan P. Lyss, Heartland Cancer Research Community Clinical Oncology Program; Michael Naughton, Washington University School of Medicine, St Louis, MO; Constance Cirrincione and Eleanor Leung, Alliance Statistics and Data Center, Duke University, Durham; Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Deborah Toppmeyer, Cancer Institute of New Jersey, New Brunswick, NJ; and Clifford Hudis, Memorial Sloan Kettering Cancer Center, New York, NY.
Clifford HudisHope S. Rugo, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; William T. Barry, Alliance Statistics and Data Center, Dana-Farber Cancer Institute; Erica L. Mayer and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Alvaro Moreno-Aspitia and Edith A. Perez, Mayo Clinic, Jacksonville, FL; Alan P. Lyss, Heartland Cancer Research Community Clinical Oncology Program; Michael Naughton, Washington University School of Medicine, St Louis, MO; Constance Cirrincione and Eleanor Leung, Alliance Statistics and Data Center, Duke University, Durham; Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Deborah Toppmeyer, Cancer Institute of New Jersey, New Brunswick, NJ; and Clifford Hudis, Memorial Sloan Kettering Cancer Center, New York, NY.
Eric P WinerHope S. Rugo, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; William T. Barry, Alliance Statistics and Data Center, Dana-Farber Cancer Institute; Erica L. Mayer and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Alvaro Moreno-Aspitia and Edith A. Perez, Mayo Clinic, Jacksonville, FL; Alan P. Lyss, Heartland Cancer Research Community Clinical Oncology Program; Michael Naughton, Washington University School of Medicine, St Louis, MO; Constance Cirrincione and Eleanor Leung, Alliance Statistics and Data Center, Duke University, Durham; Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Deborah Toppmeyer, Cancer Institute of New Jersey, New Brunswick, NJ; and Clifford Hudis, Memorial Sloan Kettering Cancer Center, New York, NY.
Dana-Farber Cancer Institute · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
SOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6M
RESEARCH BASE SUPPORT FOR COMMUNITY CLINICAL ONCOLOGY PRU10CA037447 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M, PASKETT, ELECTRA D. · 1985 to 2015
$25.3M
MEDICAL CENTER OF DELAWARE CCOPU10CA045418 · NCI · CHRISTIANA CARE HEALTH SERVICES, INC. · PI GRUBBS, STEPHEN S. · 1987 to 2014
$14.5M
Illinois Oncology Research Association Community Clinical Oncology ProgramU10CA035113 · NCI · ONCOLOGY-HEMATOLOGY ASSOC-CENTRAL ILL · PI LE-LINDQWISTER, NGUYET A. · 1985 to 2014
$10.8M
Northern Indiana Cancer Research Corsoortium, CCOPU10CA086726 · NCI · NORTHERN INDIANA CANCER RES CONSORTIUM · PI METHOD, MICHAEL · 2000 to 2014
$9.8M
NCI NIH HHS CA04326NCI NIH HHS CA04457NCI NIH HHS CA08025NCI NIH HHS CA114558NCI NIH HHS CA11789NCI NIH HHS CA12046NCI NIH HHS CA16450NCI NIH HHS CA21060NCI NIH HHS CA26806NCI NIH HHS CA29165NCI NIH HHS CA35113NCI NIH HHS CA35279NCI NIH HHS CA35421NCI NIH HHS CA37447NCI NIH HHS CA41287NCI NIH HHS CA45418NCI NIH HHS CA45564NCI NIH HHS CA45808NCI NIH HHS CA47559NCI NIH HHS CA47577NCI NIH HHS CA47642NCI NIH HHS CA59518NCI NIH HHS CA60138NCI NIH HHS CA74811NCI NIH HHS CA77298NCI NIH HHS CA77406NCI NIH HHS CA77440NCI NIH HHS CA77597NCI NIH HHS CA77651NCI NIH HHS CA77658NCI NIH HHS CA86726NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA180791NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180833NCI NIH HHS U10 CA180838NCI NIH HHS U10 CA180882
6 · The paper itself

Abstract

purposeWe compared nab-paclitaxel or ixabepilone once per week to paclitaxel with bevacizumab as first-line therapy for patients with advanced breast cancer (BC) to evaluate progression-free survival (PFS) for nab-paclitaxel or ixabepilone versus paclitaxel. PATIENTS AND

methodsEligible patients were age ≥ 18 years with chemotherapy-naive advanced BC. Patients were randomly assigned to bevacizumab with paclitaxel 90 mg/m(2) (arm A), nab-paclitaxel 150 mg/m(2) (arm B), or ixabepilone 16 mg/m(2) (arm C), once per week for 3 of 4 weeks. Planned enrollment was 900 patients, which would give 88% power to detect a hazard ratio of 0.73.

resultsIn all, 799 patients were enrolled, and 783 received treatment (97% received bevacizumab). Arm C was closed for futility at the first interim analysis (n = 241), and arm A (n = 267) and arm B (n = 275) were closed for futility at the second interim analysis. Median PFS for paclitaxel was 11 months, ixabepilone was inferior to paclitaxel (PFS, 7.4 months; hazard ratio, 1.59; 95% CI, 1.31 to 1.93; P < .001), and nab-paclitaxel was not superior to paclitaxel (PFS, 9.3 months; hazard ratio, 1.20; 95% CI, 1.00 to 1.45; P = .054). Results were concordant with overall survival; time to treatment failure was significantly shorter in both experimental arms v paclitaxel. Hematologic and nonhematologic toxicity, including peripheral neuropathy, was increased with nab-paclitaxel, with more frequent and earlier dose reductions.

conclusionIn patients with chemotherapy-naive advanced BC, ixabepilone once per week was inferior to paclitaxel, and nab-paclitaxel was not superior with a trend toward inferiority. Toxicity was increased in the experimental arms, particularly for nab-paclitaxel. Paclitaxel once per week remains the preferred palliative chemotherapy in this setting.

Indexed as

AdultAgedAged, 80 and overAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsDrug Administration ScheduleEpothilonesFemaleHumansMiddle AgedNanoparticlesNeoplasm MetastasisNeoplasm Recurrence, Local130-nm albumin-bound paclitaxelAlbuminsAntibodies, Monoclonal, HumanizedBevacizumabEpothilonesixabepilonePaclitaxel

Identifiers

PMID26056183
PMCPMC4500830
OpenAlexW2136451551

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.