Evidence map›Paper›PMID 34143979›Full record

Trial reportCancer cell2021

Durvalumab with olaparib and paclitaxel for high-risk HER2-negative stage II/III breast cancer: Results from the adaptively randomized I-SPY2 trial.

Lajos Pusztai, Christina Yau, Denise M Wolf, Hyo S Han, Lili Du, Anne M Wallace, Erica String-Reasor, Judy C Boughey, A Jo Chien, Anthony D Elias and 35 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer cell, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 231 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
231citing papers in PubMed, 8 pooled it
19.5field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

231 citing papers in PubMed, 8 syntheses or guidelines pooled it, 308 citations in OpenAlex.

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  10. Durvalumab plus Paclitaxel, with or without Capivasertib or Oleclumab, in Patients with Locally Advanced/Metastatic Triple-Negative Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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171 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

45 authors at 20 institutions in 1 country.

Lajos PusztaiBreast Medical Oncology, Yale Cancer Center, Yale School of Medicine, 333 Cedar Steet, PO Box 208032, New Haven, CT 06510, USA. Electronic address: lajos.pusztai@yale.edu.
Christina YauHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
Denise M WolfDepartment of Laboratory Medicine, University of California, San Francisco, CA 94143, USA.
Hyo S HanMedical Oncology, Moffitt Cancer Center, Tampa, FL 33612, USA.
Lili DuDepartment of Pathology, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
Anne M WallaceComprehensive Breast Health Center, University of California San Diego, La Jolla, CA 92037, USA.
Erica String-ReasorDepartment of Hematology & Oncology, University of Alabama at Birmingham, Birmingham, AL 35233, USA.
Judy C BougheyDepartment of Surgery, Mayo Clinic, Rochester, MN 55905, USA.
A Jo ChienHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
Anthony D EliasDepartment of Internal Medicine, University of Colorado, Aurora, CO 80045, USA.
Heather BeckwithMasonic Cancer Center, University of Minnesota, Minneapolis, MN 55455, USA.
Rita NandaDepartment of Medicine, University of Chicago, Chicago, IL 60637, USA.
Kathy S AlbainHematology/Oncology, Loyola University Chicago Stritch School of Medicine, Chicago, IL 60153, USA.
Amy S ClarkAbramson Cancer Center, University of Pennsylvania, Philadelphia, PA 19104, USA.
Kathleen KemmerKnight Cancer Institute, Oregon Health & Sciences University, Portland, OR 97239, USA.
Kevin KalinskyHerbert Irving Comprehensive Cancer Center, Columbia University, New York, NY 10032, USA.
Claudine IsaacsLombardi Comprehensive Care Center, Georgetown University, Washington, DC 20007, USA.
Alexandra ThomasMedical Oncology and Hematology, Wake Forest University, Winston-Salem, NC 27157, USA.
Rebecca ShatskyComprehensive Breast Health Center, University of California San Diego, La Jolla, CA 92037, USA.
Theresa L HelstenMoores Cancer Center, University of California San Diego, La Jolla, CA 92037, USA.
Andres Forero-TorresDepartment of Hematology & Oncology, University of Alabama at Birmingham, Birmingham, AL 35233, USA.
Minetta C LiuDepartment of Surgery, Mayo Clinic, Rochester, MN 55905, USA.
Lamorna Brown-SwigartDepartment of Laboratory Medicine, University of California, San Francisco, CA 94143, USA.
Emmanuel F PetricoinCenter for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, VA 20110, USA.
Julia D WulfkuhleCenter for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, VA 20110, USA.
Smita M AsareQuantum Leap Healthcare Collaborative, San Francisco, CA 94118, USA.
Amy WilsonQuantum Leap Healthcare Collaborative, San Francisco, CA 94118, USA.
Ruby SinghraoHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
Laura SitHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
Gillian L HirstHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
Scott BerryBerry Consultants, LLC, Austin, TX 78746, USA.
Ashish SanilBerry Consultants, LLC, Austin, TX 78746, USA.
Adam L AsareQuantum Leap Healthcare Collaborative, San Francisco, CA 94118, USA.
Jeffrey B MatthewsHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
Jane PerlmutterGemini Group, Ann Arbor, MI 48107, USA.
Michelle MeliskoHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
Hope S RugoHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
Richard B SchwabMoores Cancer Center, University of California San Diego, La Jolla, CA 92037, USA.
W Fraser SymmansDepartment of Pathology, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
Doug YeeMasonic Cancer Center, University of Minnesota, Minneapolis, MN 55455, USA.
Laura J Van't VeerHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
Nola M HyltonHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
Angela M DeMicheleAbramson Cancer Center, University of Pennsylvania, Philadelphia, PA 19104, USA.
Donald A BerryBerry Consultants, LLC, Austin, TX 78746, USA.
Laura J EssermanHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA 94143, USA.
University of California, San Francisco · USUniversity of California San Diego · USBerry & Associates (United States) · USQuantum Leap Healthcare Collaborative · USGeorge Mason University · USMayo Clinic in Arizona · USThe University of Texas MD Anderson Cancer Center · USUniversity of Alabama at Birmingham · USUniversity of Minnesota Medical Center · USUniversity of Pennsylvania · USColumbia University Irving Medical Center · USGemini Computers (United States) · USGeorgetown University · USLoyola University Chicago · USMoffitt Cancer Center · USOregon Health & Science University · USUniversity of Chicago · USUniversity of Colorado Anschutz Medical Campus · USWake Forest University · USYale Cancer Center · US

Funding

The I SPY 2.2 TRIAL: Evolving to Imaging and Molecular Biomarker Response Directed Adaptive Sequential Treatment to Optimize Breast Cancer OutcomesP01CA210961 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Nola M. Hylton-Watson · 2017 to 2026
$22.9M
Modeling the Impact of Targeted Therapy Based on Breast Cancer SubtypesU01CA187945 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI BERRY, DONALD A, ESSERMAN, LAURA J · 2014 to 2018
$2.5M
preoprative chemotherapy for breast cancerR01CA106290 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI PUSZTAI, LAJOS · 2005 to 2007
$570k
NCI NIH HHS P01 CA210961NCI NIH HHS R01 CA106290NCI NIH HHS U01 CA187945
6 · The paper itself

Abstract

The combination of PD-L1 inhibitor durvalumab and PARP inhibitor olaparib added to standard paclitaxel neoadjuvant chemotherapy (durvalumab/olaparib/paclitaxel [DOP]) was investigated in the phase II I-SPY2 trial of stage II/III HER2-negative breast cancer. Seventy-three participants were randomized to DOP and 299 to standard of care (paclitaxel) control. DOP increased pathologic complete response (pCR) rates in all HER2-negative (20%-37%), hormone receptor (HR)-positive/HER2-negative (14%-28%), and triple-negative breast cancer (TNBC) (27%-47%). In HR-positive/HER2-negative cancers, MammaPrint ultra-high (MP2) cases benefited selectively from DOP (pCR 64% versus 22%), no benefit was seen in MP1 cancers (pCR 9% versus 10%). Overall, 12.3% of patients in the DOP arm experienced immune-related grade 3 adverse events versus 1.3% in control. Gene expression signatures associated with immune response were positively associated with pCR in both arms, while a mast cell signature was associated with non-pCR. DOP has superior efficacy over standard neoadjuvant chemotherapy in HER2-negative breast cancer, particularly in a highly sensitive subset of high-risk HR-positive/HER2-negative patients.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesFemaleFollow-Up StudiesHumansMiddle AgedNeoadjuvant TherapyPaclitaxelPhthalazinesPiperazinesPrognosisAntibodies, MonoclonaldurvalumabERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesolaparibPaclitaxelPhthalazinesPiperazinesbreast cancerclinical trialDNA repair inhibitorimmunotherapy

Identifiers

PMID34143979
PMCPMC11064785
OpenAlexW3172174831

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

Registered trials

None linked

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.