Evidence map›Paper›PMID 39277671›Full record

Trial reportNature medicine2024

Datopotamab-deruxtecan in early-stage breast cancer: the sequential multiple assignment randomized I-SPY2.2 phase 2 trial.

Katia Khoury, Jane L Meisel, Christina Yau, Hope S Rugo, Rita Nanda, Marie Davidian, Butch Tsiatis, A Jo Chien, Anne M Wallace, Mili Arora and 47 more

Abstract readClinical Trial, Phase IIRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–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.

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

11 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Escalation and optimisation of primary breast cancer treatment with antibody-drug conjugates.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2025
    Review
  10. Review
  11. Article
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

57 authors.

Katia Khoury *University of Alabama at Birmingham, Birmingham, AL, USA.ORCID http://orcid.org/0000-0003-3899-8649
Jane L Meisel *Emory University, Atlanta, GA, USA.
Christina YauUniversity of California San Francisco, San Francisco, CA, USA.
Hope S RugoUniversity of California San Francisco, San Francisco, CA, USA.ORCID http://orcid.org/0000-0001-6710-4814
Rita NandaUniversity of Chicago, Chicago, IL, USA.ORCID http://orcid.org/0000-0001-5248-0876
Marie DavidianNorth Carolina State University, Raleigh, NC, USA.
Butch TsiatisNorth Carolina State University, Raleigh, NC, USA.
A Jo ChienUniversity of California San Francisco, San Francisco, CA, USA.
Anne M WallaceUniversity of California San Diego, San Diego, CA, USA.
Mili AroraUniversity of California Davis, Davis, CA, USA.
Mariya RozenblitYale University, New Haven, CT, USA.
Dawn L HershmanColumbia University, New York, NY, USA.
Alexandra ZimmerOregon Health Sciences University, Portland, OR, USA.ORCID http://orcid.org/0000-0001-6789-0982
Amy S ClarkUniversity of Pennsylvania, Philadelphia, PA, USA.
Heather BeckwithUniversity of Minnesota, Minneapolis, MN, USA.
Anthony D EliasUniversity of Colorado Denver, Denver, CO, USA.
Erica Stringer-ReasorUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Judy C BougheyThe Mayo Clinic, Rochester, MN, USA.ORCID http://orcid.org/0000-0003-3820-3228
Chaitali NangiaHOAG Family Cancer Institute, Newport Beach, CA, USA.
Christos VaklavasHuntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.ORCID http://orcid.org/0000-0002-9919-2748
Coral OmeneCooperman Barnabas Medical Center, New Brunswick, NJ, USA.
Kathy S AlbainStritch School of Medicine, Loyola University Chicago, Chicago, IL, USA.
Kevin M KalinskyEmory University, Atlanta, GA, USA.ORCID http://orcid.org/0000-0002-3113-7902
Claudine IsaacsLombardi Comprehensive Cancer Center, Georgetown University, Washington DC, USA.ORCID http://orcid.org/0000-0002-9646-1260
Jennifer TsengCity of Hope Orange County Lennar Foundation Cancer Center, Orange County, CA, USA.
Evanthia T Roussos TorresUniversity of Southern California, Los Angeles, CA, USA.ORCID http://orcid.org/0000-0002-0740-5102
Brittani ThomasSparrow Health System, Lansing, MI, USA.
Alexandra ThomasWake Forest University, Winston-Salem, NC, USA.ORCID http://orcid.org/0000-0001-9022-2229
Amy SanfordSanford Health, Sioux Falls, SD, USA.
Ronald BalassanianUniversity of California San Francisco, San Francisco, CA, USA.
Cheryl EwingUniversity of California San Francisco, San Francisco, CA, USA.
Kay YeungUniversity of California San Diego, San Diego, CA, USA.
Candice SauderUniversity of California Davis, Davis, CA, USA.ORCID http://orcid.org/0000-0001-6869-8634
Tara SanftYale University, New Haven, CT, USA.
Lajos PusztaiYale University, New Haven, CT, USA.ORCID http://orcid.org/0000-0001-9632-6686
Meghna S TrivediColumbia University, New York, NY, USA.
Ashton OuthaythipOregon Health Sciences University, Portland, OR, USA.
Wen LiUniversity of California San Francisco, San Francisco, CA, USA.
Natsuko OnishiUniversity of California San Francisco, San Francisco, CA, USA.ORCID http://orcid.org/0000-0003-4495-9187
Adam L AsareUniversity of California San Francisco, San Francisco, CA, USA.
Philip BeinekeQuantum Leap Healthcare Collaborative, San Francisco, CA, USA.
Peter NorwoodQuantum Leap Healthcare Collaborative, San Francisco, CA, USA.
Lamorna Brown-SwigartUniversity of California San Francisco, San Francisco, CA, USA.ORCID http://orcid.org/0000-0003-2076-5177
Gillian L HirstUniversity of California San Francisco, San Francisco, CA, USA.ORCID http://orcid.org/0000-0002-4502-0035
Jeffrey B MatthewsUniversity of California San Francisco, San Francisco, CA, USA.
Brian MooreWake Forest University, Winston-Salem, NC, USA.
W Fraser SymmansUniversity of Texas MD Anderson Cancer Center, Houston, TX, USA.
Elissa PriceUniversity of California San Francisco, San Francisco, CA, USA.
Carolyn BeedleUniversity of California San Francisco, San Francisco, CA, USA.
Jane PerlmutterThe Gemini Group, Ann Arbor, MI, USA.
Paula PohlmannUniversity of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0001-7914-5162
Rebecca A ShatskyUniversity of California San Diego, San Diego, CA, USA.
Angela DeMicheleUniversity of Pennsylvania, Philadelphia, PA, USA.ORCID http://orcid.org/0000-0003-1297-4251
Douglas YeeUniversity of Minnesota, Minneapolis, MN, USA.ORCID http://orcid.org/0000-0002-3387-4009
Laura J van 't VeerUniversity of California San Francisco, San Francisco, CA, USA.ORCID http://orcid.org/0000-0002-9838-8298
Nola M HyltonUniversity of California San Francisco, San Francisco, CA, USA.
Laura J EssermanUniversity of California San Francisco, San Francisco, CA, USA. laura.esserman@ucsf.edu.ORCID http://orcid.org/0000-0001-9202-4568

Funding

VIRAL MALIGNANCYP30CA023100 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Jesse Nodora · 1985 to 2026
$124.9M
Women's CancerP30CA077598 · NCI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI Jeffrey S. Miller · 1998 to 2026
$100.4M
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
PROJECT 3 – BIOLOGY OF DNA DEAMINASES IN CANCERP01CA234228 · NCI · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI Rommie E Amaro · 2019 to 2026
$14.5M
Strategy for combining circulating tumor DNA (ctDNA) and magnetic resonance imaging (MRI) measures of tumor burden for prediction of response and outcome in neoadjuvant-treated early breast cancerR01CA255442 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI LI, WEN, MAGBANUA, MARK JESUS · 2021 to 2025
$3.3M
Disrupting insulin receptor function in breast cancerR01CA251600 · NCI · UNIVERSITY OF MINNESOTA · PI YEE, DOUGLAS · 2020 to 2024
$1.7M
Next-generation SMARTs for Discovery and Evaluation of Sequential Cancer Therapeutic StrategiesR01CA280970 · NCI · DUKE UNIVERSITY · PI Eric Benjamin Laber · 2024 to 2026
$1.1M
NCI NIH HHS P01 CA210961NCI NIH HHS P01 CA234228NCI NIH HHS P30 CA023100NCI NIH HHS P30 CA077598NCI NIH HHS R01 CA251600NCI NIH HHS R01 CA255442NCI NIH HHS R01 CA280970U.S. Department of Health & Human Services | National Institutes of Health (NIH) P01CA210961
6 · The paper itself

Abstract

Among the goals of patient-centric care are the advancement of effective personalized treatment, while minimizing toxicity. The phase 2 I-SPY2.2 trial uses a neoadjuvant sequential therapy approach in breast cancer to further these goals, testing promising new agents while optimizing individual outcomes. Here we tested datopotamab-deruxtecan (Dato-DXd) in the I-SPY2.2 trial for patients with high-risk stage 2/3 breast cancer. I-SPY2.2 uses a sequential multiple assignment randomization trial design that includes three sequential blocks of biologically targeted neoadjuvant treatment: the experimental agent(s) (block A), a taxane-based regimen tailored to the tumor subtype (block B) and doxorubicin-cyclophosphamide (block C). Patients are randomized into arms consisting of different investigational block A treatments. Algorithms based on magnetic resonance imaging and core biopsy guide treatment redirection after each block, including the option of early surgical resection in patients predicted to have a high likelihood of pathological complete response, the primary endpoint. There are two primary efficacy analyses: after block A and across all blocks for the six prespecified breast cancer subtypes (defined by clinical hormone receptor/human epidermal growth factor receptor 2 (HER2) status and/or the response-predictive subtypes). We report results of 103 patients treated with Dato-DXd. While Dato-DXd did not meet the prespecified threshold for success (graduation) after block A in any subtype, the treatment strategy across all blocks graduated in the hormone receptor-negative HER2

Indexed as

Breast NeoplasmsNeoadjuvant TherapyAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCamptothecinCyclophosphamideDoxorubicinErb-b2 Receptor Tyrosine KinasesFemaleHumansImmunoconjugatesMiddle AgedNeoplasm StagingTrastuzumabAntibodies, Monoclonal, HumanizedCamptothecinCyclophosphamideDoxorubicinErb-b2 Receptor Tyrosine KinasesImmunoconjugatesTrastuzumabtrastuzumab deruxtecan

Identifiers

PMID39277671
PMCPMC12044543

What OpenQuestion holds

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Registered trials

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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.