Evidence map›Paper›PMID 37061619›Full record

Trial reportBreast cancer research and treatment2023

A phase II study of neoadjuvant atezolizumab and nab-paclitaxel in patients with anthracycline-resistant early-stage triple-negative breast cancer.

Clinton Yam, Elizabeth A Mittendorf, Haven R Garber, Ryan Sun, Senthil Damodaran, Rashmi K Murthy, David Ramirez, Meghan Karuturi, Rachel M Layman, Nuhad Ibrahim and 15 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Breast cancer research and treatment, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02530489 (Triple-Negative First-Line Study), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
3.5field-weighted citation impact, top 7% 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.

NCT02530489 phase2completednot on this map

Triple-Negative First-Line Study: Neoadjuvant Trial of Nab-Paclitaxel and MPDL3280A, a PDL-1 Inhibitor in Patients With Triple Negative Breast Cancer

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2016 to 2025Enrolled37ConditionsBreast Adenocarcinoma, Invasive Breast Carcinoma, Triple-Negative Breast CarcinomaArmsAtezolizumab, Nab-paclitaxel
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

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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

25 authors at 3 institutions in 1 country.

Clinton YamDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Dan L. Duncan Building (CPB5.3542), 1515 Holcombe Blvd. Unit 1354, Houston, TX, 77030, USA. cyam@mdanderson.org.
Elizabeth A MittendorfDivision of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA.
Haven R GarberDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Dan L. Duncan Building (CPB5.3542), 1515 Holcombe Blvd. Unit 1354, Houston, TX, 77030, USA.
Ryan SunDepartment of Biostatistics, Division of Basic Sciences, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Senthil DamodaranDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Dan L. Duncan Building (CPB5.3542), 1515 Holcombe Blvd. Unit 1354, Houston, TX, 77030, USA.
Rashmi K MurthyDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Dan L. Duncan Building (CPB5.3542), 1515 Holcombe Blvd. Unit 1354, Houston, TX, 77030, USA.
David RamirezDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Dan L. Duncan Building (CPB5.3542), 1515 Holcombe Blvd. Unit 1354, Houston, TX, 77030, USA.
Meghan KaruturiDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Dan L. Duncan Building (CPB5.3542), 1515 Holcombe Blvd. Unit 1354, Houston, TX, 77030, USA.
Rachel M LaymanDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Dan L. Duncan Building (CPB5.3542), 1515 Holcombe Blvd. Unit 1354, Houston, TX, 77030, USA.
Nuhad IbrahimDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Dan L. Duncan Building (CPB5.3542), 1515 Holcombe Blvd. Unit 1354, Houston, TX, 77030, USA.
Gaiane M RauchDepartment of Breast Imaging, Division of Diagnostic Imaging, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Beatriz E AdradaDepartment of Breast Imaging, Division of Diagnostic Imaging, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Rosalind P CandelariaDepartment of Breast Imaging, Division of Diagnostic Imaging, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jason B WhiteDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Dan L. Duncan Building (CPB5.3542), 1515 Holcombe Blvd. Unit 1354, Houston, TX, 77030, USA.
Elizabeth RavenbergDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Dan L. Duncan Building (CPB5.3542), 1515 Holcombe Blvd. Unit 1354, Houston, TX, 77030, USA.
Alyson ClaybornDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Dan L. Duncan Building (CPB5.3542), 1515 Holcombe Blvd. Unit 1354, Houston, TX, 77030, USA.
Qing Qing DingDepartment of Pathology, Division of Pathology-Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
W Fraser SymmansDepartment of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Sabitha PrabhakaranDepartment of Genomic Medicine, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Alastair M ThompsonSection of Breast Surgery, Division of Surgical Oncology, Baylor College of Medicine, Houston, TX, USA.
Vicente ValeroDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Dan L. Duncan Building (CPB5.3542), 1515 Holcombe Blvd. Unit 1354, Houston, TX, 77030, USA.
Debu TripathyDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Dan L. Duncan Building (CPB5.3542), 1515 Holcombe Blvd. Unit 1354, Houston, TX, 77030, USA.
Lei HuoDepartment of Pathology, Division of Pathology-Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Stacy L MoulderDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Dan L. Duncan Building (CPB5.3542), 1515 Holcombe Blvd. Unit 1354, Houston, TX, 77030, USA.
Jennifer K LittonDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Dan L. Duncan Building (CPB5.3542), 1515 Holcombe Blvd. Unit 1354, Houston, TX, 77030, USA. jlitton@mdanderson.org.ORCID http://orcid.org/0000-0001-8390-4985
The University of Texas MD Anderson Cancer Center · USBaylor College of Medicine · USBrigham and Women's Hospital · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Brigham and Women's Hospital Karen Hale Distinguished Chair in Surgical OncologyBrigham and Women's Hospital RobConquer Cancer Foundation 12266Conquer Cancer Foundation 2020CDABC-5423266503NCI NIH HHS P30 CA016672University of Texas MD Anderson Cancer Center AllisonUniversity of Texas MD Anderson Cancer Center Brian Grove Endowed Fellowship for Breast Medical OncologyUniversity of Texas MD Anderson Cancer Center Susan Papizan Dolan Fellowship in Breast Oncology
6 · The paper itself

Abstract

purposeNeoadjuvant anti-PD-(L)1 therapy improves the pathological complete response (pCR) rate in unselected triple-negative breast cancer (TNBC). Given the potential for long-term morbidity from immune-related adverse events (irAEs), optimizing the risk-benefit ratio for these agents in the curative neoadjuvant setting is important. Suboptimal clinical response to initial neoadjuvant therapy (NAT) is associated with low rates of pCR (2-5%) and may define a patient selection strategy for neoadjuvant immune checkpoint blockade. We conducted a single-arm phase II study of atezolizumab and nab-paclitaxel as the second phase of NAT in patients with doxorubicin and cyclophosphamide (AC)-resistant TNBC (NCT02530489).

methodsPatients with stage I-III, AC-resistant TNBC, defined as disease progression or a < 80% reduction in tumor volume after 4 cycles of AC, were eligible. Patients received atezolizumab (1200 mg IV, Q3weeks × 4) and nab-paclitaxel (100 mg/m

resultsFrom 2/15/2016 through 1/29/2021, 37 patients with AC-resistant TNBC were enrolled. The pCR/RCB-I rate was 46%. No new safety signals were observed. Seven patients (19%) discontinued atezolizumab due to irAEs.

conclusionThis study met its primary endpoint, demonstrating a promising signal of activity in this high-risk population (pCR/RCB-I = 46% vs 5% in historical controls), suggesting that a response-adapted approach to the utilization of neoadjuvant immunotherapy should be considered for further evaluation in a randomized clinical trial.

Indexed as

Breast NeoplasmsTriple Negative Breast NeoplasmsAlbuminsAnthracyclinesAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansNeoadjuvant TherapyPaclitaxel130-nm albumin-bound paclitaxelAlbuminsAnthracyclinesAntibodies, Monoclonal, HumanizedatezolizumabPaclitaxelAtezolizumabChemotherapy resistancePhase II trialTriple-negative breast cancer

Identifiers

PMID37061619
PMCPMC12247189
OpenAlexW4365816066

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.