Evidence map›Paper›PMID 30939096›Full record

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

Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer.

Sara M Tolaney, Hao Guo, Sonia Pernas, William T Barry, Deborah A Dillon, Lauren Ritterhouse, Bryan P Schneider, Fei Shen, Kit Fuhrman, Michele Baltay and 16 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
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 is linked to trial NCT05058183 (Safe De-escalation of Chemotherapy for Stage 1 Breast Cancer), which is not on this map. Cited by 142 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
142citing papers in PubMed, 9 pooled it
–field-weighted citation impact
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.

NCT05058183 narecruitingnot on this mapstarted 2023, after this paper: background citation

Safe De-escalation of Chemotherapy for Stage 1 Breast Cancer

TypeinterventionalSponsorRoyal Marsden NHS Foundation TrustRan2023 to 2028Enrolled400ConditionsBreast CancerArmsctDNA
3 · Its place in the literature

Who cites it

142 citing papers in PubMed, 9 syntheses or guidelines pooled it.

  1. Guideline
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  3. SEOM-GEICAM-SOLTI clinical guidelines for early-stage breast cancer (2022).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
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  10. Trial
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  16. Review
  17. Article
  18. Review
  19. Headwinds in Breast Cancer Research: The Case for Pragmatic Radiotherapy De-escalation Studies.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
    Article
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors.

Sara M Tolaney1Dana-Farber Cancer Institute, Boston, MA.
Hao Guo1Dana-Farber Cancer Institute, Boston, MA.
Sonia Pernas1Dana-Farber Cancer Institute, Boston, MA.
William T Barry1Dana-Farber Cancer Institute, Boston, MA.
Deborah A DillonBrigham and Women's Hospital, Boston, MA.
Lauren RitterhouseBrigham and Women's Hospital, Boston, MA.
Bryan P Schneider5Indiana University School of Medicine, Indianapolis, IN.
Fei Shen5Indiana University School of Medicine, Indianapolis, IN.
Kit FuhrmanNanoString Technologies, Seattle, WA.
Michele BaltayBrigham and Women's Hospital, Boston, MA.
Chau T DangMemorial Sloan Kettering Cancer Center, New York, NY.
Denise A Yardley9Sarah Cannon Cancer Center, Nashville, TN.
Beverly MoyMassachusetts General Hospital, Boston, MA.
P Kelly MarcomDuke Cancer Institute, Durham, NC.
Kathy S AlbainLoyola University Chicago Stritch School of Medicine, Maywood, IL.
Hope S RugoUniversity of California, San Francisco, San Francisco, CA.
Mathew J EllisBaylor Clinic Lester and Sue Smith Breast Center, Houston, TX.
Iuliana ShapiraHofstra North Shore-LIJ School of Medicine, New Hyde Park, NY.
Antonio C WolffJohns Hopkins University, Baltimore, MD.
Lisa A CareyUniversity of North Carolina, Chapel Hill, NC.
Beth Overmoyer1Dana-Farber Cancer Institute, Boston, MA.
Ann H Partridge1Dana-Farber Cancer Institute, Boston, MA.
Clifford A HudisMemorial Sloan Kettering Cancer Center, New York, NY.
Ian E Krop1Dana-Farber Cancer Institute, Boston, MA.
Harold J Burstein1Dana-Farber Cancer Institute, Boston, MA.
Eric P Winer1Dana-Farber Cancer Institute, Boston, MA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeThe Adjuvant Paclitaxel and Trastuzumab trial was designed to address treatment of patients with small human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The primary analysis of the Adjuvant Paclitaxel and Trastuzumab trial demonstrated a 3-year disease-free survival (DFS) of 98.7%. In this planned secondary analysis, we report longer-term outcomes and exploratory results to characterize the biology of small HER2-positive tumors and genetic factors that may predispose to paclitaxel-induced peripheral neuropathy (TIPN). PATIENTS AND

methodsIn this phase II study, patients with HER2-positive breast cancer with tumors 3 cm or smaller and negative nodes received paclitaxel (80 mg/m

resultsA total of 410 patients were enrolled from October 2007 to September 2010. After a median follow-up of 6.5 years, there were 23 DFS events. The 7-year DFS was 93% (95% CI, 90.4 to 96.2) with four (1.0%) distant recurrences, 7-year OS was 95% (95% CI, 92.4 to 97.7), and 7-year RFI was 97.5% (95% CI, 95.9 to 99.1). PAM50 analyses (n = 278) showed that most tumors were HER2-enriched (66%), followed by luminal B (14%), luminal A (13%), and basal-like (8%). Genotyping (n = 230) identified one single-nucleotide polymorphism,

conclusionWith longer follow-up, adjuvant paclitaxel and trastuzumab is associated with excellent long-term outcomes. Distribution of PAM50 intrinsic subtypes in small HER2-positive tumors is similar to that previously reported for larger tumors.

Indexed as

Gene Expression Regulation, NeoplasticAdultAgedAged, 80 and overBreast NeoplasmsBreast Neoplasms, MaleChemotherapy, AdjuvantDisease-Free SurvivalErb-b2 Receptor Tyrosine KinasesFemaleFollow-Up StudiesGenetic Predisposition to DiseaseGenotypeHumansLymph NodesMaleERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesPaclitaxelTrastuzumab

Identifiers

PMID30939096
PMCPMC7587424

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.