Evidence map›Paper›PMID 42504645›Full record

Trial reportCancer medicine2026

A Phase I/II Study of Ibrutinib Plus Trastuzumab in HER2-Positive Metastatic Breast Cancer.

Joyce O'Shaughnessy, Andrea Glidden, Tracy Locke, Amy Scales, Elizabeth Gatewood, Jean-Philippe Blanck, Jessica Castaneda-Gill, Sharlin Patel, Yolanda D Mahnke, Xuan Wang and 1 more

Abstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in Cancer medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Trial
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

11 authors.

Joyce O'ShaughnessyTexas Oncology: Baylor University Cancer Center, Dallas, Texas, USA.ORCID https://orcid.org/0000-0002-2955-5523
Andrea GliddenSarah Cannon Research Institute, Nashville, Tennessee, USA.
Tracy LockeSarah Cannon Research Institute, Nashville, Tennessee, USA.
Amy ScalesSarah Cannon Research Institute, Nashville, Tennessee, USA.
Elizabeth GatewoodBaylor Research Institute Flow Cytometry SRL, Dallas, Texas, USA.
Jean-Philippe BlanckBaylor Research Institute Flow Cytometry SRL, Dallas, Texas, USA.
Jessica Castaneda-GillBaylor Research Institute Genomics Core, Dallas, Texas, USA.
Sharlin PatelBaylor Research Institute Genomics Core, Dallas, Texas, USA.
Yolanda D MahnkeFlowKnowHow LLC, Cos Cob, Connecticut, USA.ORCID https://orcid.org/0000-0002-2727-9887
Xuan WangBaylor Research Institute, Dallas, Texas, USA.
Page BlasBaylor Research Institute, Dallas, Texas, USA.ORCID https://orcid.org/0009-0008-5044-1169

Funding

Pharmacyclics
6 · The paper itself

Abstract

Ibrutinib has demonstrated inhibition of ErbB/HER tyrosine kinases in preclinical models. This Phase I/II study investigated the safety, efficacy, and immunomodulatory effects of ibrutinib in combination with trastuzumab in patients with HER2-positive metastatic breast cancer (MBC) whose disease had progressed on ado-trastuzumab emtansine therapy. In Phase I, cohorts of three patients received ibrutinib 560 mg or 420 mg by mouth once daily combined with standard dosing of trastuzumab. Phase II enrolled additional patients to assess the primary endpoint of clinical benefit rate (CBR) at 420 mg ibrutinib plus trastuzumab. Flow cytometry and NanoString analyses were performed on peripheral blood mononuclear cells. Overall, 26 patients were enrolled. Patients received a median of three prior regimens containing a HER2-targeted therapy in any setting. The most common treatment-related adverse events were bruising, rash, fatigue, and thrombocytopenia. Four patients (15%) experienced cardiac adverse events, including decreased left ventricular ejection fraction in two patients. The CBR of ibrutinib plus trastuzumab was 19.2% (95% confidence interval: 6.6-39.4). Flow cytometry of T- and natural killer (NK)-cell and myeloid-cell panels showed that treatment statistically significantly decreased T helper 17 (T

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesTrastuzumabAdenineAdultAgedFemaleHumansMiddle AgedNeoplasm MetastasisPiperidinesPyrimidinesAdenineERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesibrutinibPiperidinesPyrimidinesTrastuzumabHER2‐positive metastatic breast canceribrutinibT helper 1 cellsT helper 2 cellstrastuzumab

Identifiers

PMID42504645
PMCPMC13403036

What OpenQuestion holds

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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.