Evidence map›Paper›PMID 38797949›Full record

Trial reportCancer control : journal of the Moffitt Cancer Center

An Open-Label Study of Subcutaneous CpG Oligodeoxynucleotide (PF03512676) in Combination with Trastuzumab in Patients with Metastatic HER2+ Breast Cancer.

Dionisia Quiroga, Robert Wesolowski, Sara Zelinskas, Ashley Pinette, Brooke Benner, Emily Schwarz, Himanshu Savardekar, Courtney Johnson, Andrew Stiff, Lianbo Yu and 5 more

Abstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer control : journal of the Moffitt Cancer Center. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

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

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

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. 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

15 authors.

Dionisia QuirogaPelotonia Institute for Immuno-Oncology, The James Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.ORCID 0000-0003-3388-7069
Robert WesolowskiPelotonia Institute for Immuno-Oncology, The James Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Sara ZelinskasPelotonia Institute for Immuno-Oncology, The James Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Ashley PinetteDepartment of Surgery, The Ohio State University, Columbus, OH, USA.
Brooke BennerPelotonia Institute for Immuno-Oncology, The James Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Emily SchwarzPelotonia Institute for Immuno-Oncology, The James Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Himanshu SavardekarPelotonia Institute for Immuno-Oncology, The James Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Courtney JohnsonDepartment of Surgery, The Ohio State University, Columbus, OH, USA.
Andrew StiffPelotonia Institute for Immuno-Oncology, The James Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Lianbo YuCenter for Biostatistics, The Ohio State University, Columbus, OH, USA.
Erin MacraeDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, OH, USA.
Maryam LustbergDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, OH, USA.
Ewa MrozekDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, OH, USA.
Bhuvaneswari RamaswamyDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University, Columbus, OH, USA.
William E CarsonPelotonia Institute for Immuno-Oncology, The James Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Daniel G. Stover · 1985 to 2026
$132.3M
TWO SIGNAL REQUIREMENT FOR NATURAL KILLER IMMUNITYP01CA095426 · NCI · OHIO STATE UNIVERSITY · PI TRIDANDAPANI, SUSHEELA · 2002 to 2016
$29.6M
ONOCOLOGY TRAINING GRANTT32CA009338 · NCI · OHIO STATE UNIVERSITY · PI BYRD, JOHN C., POLLOCK, RAPHAEL E. · 1985 to 2018
$8.3M
A Program of Immune-Based Treatments for CancerK24CA093670 · NCI · OHIO STATE UNIVERSITY · PI CARSON, WILLIAM E. · 2002 to 2012
$1.7M
CTSA Predoctoral T32 at the Ohio State UniversityT32TR004543 · NCATS · OHIO STATE UNIVERSITY · PI GINNY L BUMGARDNER · 2023 to 2026
$1.2M
Training Hematology and Oncology Fellows in Clinical ResearchT32CA247815 · NCI · OHIO STATE UNIVERSITY · PI VERSCHRAEGEN, CLAIRE F., WESOLOWSKI, ROBERT · 2020 to 2024
$862k
NCATS NIH HHS T32 TR004543NCI NIH HHS K24 CA093670NCI NIH HHS P01 CA095426NCI NIH HHS P30 CA016058NCI NIH HHS T32 CA009338NCI NIH HHS T32 CA247815
6 · The paper itself

Abstract

objectivesCpG ODN is a Toll-like receptor 9 agonist with immunotherapeutic potential for many cancer types, including aggressive breast cancers. There is strong interest in utilizing CpG ODN as an adjuvant to improve clinical efficacy of current treatments and immunogenicity of breast cancers not traditionally responsive to active immunotherapy, such as those that are human epidermal growth factor receptor 2 (HER2)-positive. This study aimed to study the efficacy and safety of combination CpG ODN plus anti-HER2 antibody trastuzumab treatment in patients with advanced/metastatic breast cancer.

methodsThis single-arm, open-label phase II clinical trial treated patients (n = 6) with advanced/metastatic HER2-positive breast cancer with weekly subcutaneous CpG ODN and trastuzumab. Patients may have received any number of prior therapies to be enrolled (most enrolled at median 1 prior line of chemotherapy). Peripheral blood was collected at baseline and weeks 2, 6, 12, and 18 for immune analyses. Six patients were enrolled and 50% achieved stable disease (SD) response.

resultsMedian PFS was 8.3 months. Three of the six patients enrolled opted to stop treatment due to tolerability issues. Multiplex assay for cytokine measurements revealed significantly higher VEGF-D levels at week 2 compared to baseline. Peripheral blood mononuclear cells analyzed by flow cytometry showed a significant increase in monocytic MDSC between weeks 6 and 12. Patients with progressive disease tended to have higher levels of week 6 monocytic MDSC and PD-1+ T cells than patients with SD. NK cell populations did not significantly change throughout treatment.

conclusionsCpG ODN and trastuzumab treatment of metastatic HER2 + breast cancer was safe but was not tolerable for all patients. This combination did induce potentially predictive immune profile changes in treated patients with metastatic HER2 + breast cancer, the significance of which needs to be further explored.

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesOligodeoxyribonucleotidesTrastuzumabAdultAgedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMiddle AgedCPG-oligonucleotideERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesOligodeoxyribonucleotidesTrastuzumabbreast cancerclinical trialsCpG ODNhuman epidermal growth factor receptor 2immunotherapyTLR9toll-like receptor 9trastuzumab

Identifiers

PMID38797949
PMCPMC11129578

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.