Evidence map›Paper›PMID 39625569›Full record

Trial reportBreast cancer research and treatment2025

Pexidartinib and standard neoadjuvant therapy in the adaptively randomized I-SPY2 trial for early breast cancer.

Hope S Rugo, Mike Campbell, Christina Yau, A Jo Chien, Anne M Wallace, Claudine Isaacs, Judy C Boughey, Hyo S Han, Meredith Buxton, Julia L Clennell and 13 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01042379 (I-SPY Trial), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 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.

NCT01042379 phase2recruitingnot on this map

I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)

TypeinterventionalSponsorQuantumLeap Healthcare CollaborativeRan2010 to 2031Enrolled5,000ConditionsBreast Neoplasms, Breast Cancer, Breast Tumors, AngiosarcomaArmsStandard Therapy, AMG 386 with or without Trastuzumab, AMG 479 (Ganitumab) plus Metformin, MK-2206 with or without Trastuzumab, AMG 386 and Trastuzumab
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Macrophage Plasticity in Cancer Therapy: Function, Timing, and Tradeoffs.International journal of molecular sciences · 2026
    Review
  5. Article
  6. Review
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

23 authors.

Hope S RugoUniversity of California San Francisco, Box 1710, San Francisco, CA, 94143, USA. hope.rugo@ucsf.edu.ORCID http://orcid.org/0000-0001-6710-4814
Mike CampbellUniversity of California San Francisco, Box 1710, San Francisco, CA, 94143, USA.
Christina YauUniversity of California San Francisco, Box 1710, San Francisco, CA, 94143, USA.
A Jo ChienUniversity of California San Francisco, Box 1710, San Francisco, CA, 94143, USA.
Anne M WallaceUniversity of California San Diego, San Diego, CA, USA.
Claudine IsaacsGeorgetown University, Washington, DC, USA.
Judy C BougheyMayo Clinic, Rochester, MN, USA.
Hyo S HanMoffitt Cancer Center, Tampa, FL, USA.
Meredith BuxtonUniversity of California San Francisco, Box 1710, San Francisco, CA, 94143, USA.
Julia L ClennellUniversity of California San Francisco, Box 1710, San Francisco, CA, 94143, USA.
Smita M AsareQuantum Leap Healthcare Collaborative, San Francisco, CA, USA.
Katherine SteegUniversity of California San Francisco, Box 1710, San Francisco, CA, 94143, USA.
Amy WilsonQuantum Leap Healthcare Collaborative, San Francisco, CA, USA.
Ruby SinghraoUniversity of California San Francisco, Box 1710, San Francisco, CA, 94143, USA.
Jeffrey B MatthewsUniversity of California San Francisco, Box 1710, San Francisco, CA, 94143, USA.
Jane PerlmutterGemini Group, Ann Arbor, MI, USA.
W Fraser SymmansUniversity of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nola M HyltonUniversity of California San Francisco, Box 1710, San Francisco, CA, 94143, USA.
Angela M DeMicheleUniversity of Pennsylvania, Philadelphia, PA, USA.
Douglas YeeUniversity of Minnesota, Minneapolis, MN, USA.
Laura J Van't VeerUniversity of California San Francisco, Box 1710, San Francisco, CA, 94143, USA.
Donald A BerryBerry Consultants, LLC, Houston, TX, USA.
Laura J EssermanUniversity of California San Francisco, Box 1710, San Francisco, CA, 94143, USA.

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
NCI NIH HHS P01 CA210961NIH HHS P01CA210961
6 · The paper itself

Abstract

purposeWe investigated the small-molecule receptor tyrosine kinase-inhibitor of colony-stimulating factor-1 receptor pexidartinib in the stage II/III breast cancer in the I-SPY2 platform trial.

methodsI-SPY2 is an adaptive platform trial that features multiple arms of experimental agents administered on a background of standard neoadjuvant therapy with paclitaxel and adriamycin/cyclophosphamide, followed by definitive surgery. The adaptive randomization engine preferentially assigns patients based upon cumulative performance of each agent in a given breast cancer subtype based on hormone receptor and HER2 receptor status. The study endpoint is pathologic complete response.

resultsA total of 9 participants were randomized to receive pexidartinib with neoadjuvant paclitaxel before enrollment was halted due to a serious adverse event of vanishing bile duct syndrome. No participants received a full course of the study drug.

conclusionAlthough there remains interest in agents targeting CSF-1, hepatic toxicity appears to be a limiting factor for their use in early breast cancer.

trial registrationNCT01042379 ( www. CLINICALTRIALS: gov/ct2/show/NCT01042379 ).

Indexed as

AminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsPyrrolesAdultAgedCyclophosphamideDoxorubicinErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedNeoadjuvant TherapyNeoplasm StagingPaclitaxelTreatment OutcomeAminopyridinesCyclophosphamideDoxorubicinErb-b2 Receptor Tyrosine KinasesPaclitaxelpexidartinibPyrrolesBreast cancerClinical trialColony-stimulating factor-1Pexidartinib

Identifiers

PMID39625569
PMCPMC11785665

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.