Evidence map›Paper›PMID 33799597›Full record

ArticleCancers2021

Phase Ib Trial of Copanlisib, A Phosphoinositide-3 Kinase (PI3K) Inhibitor, with Trastuzumab in Advanced Pre-Treated HER2-Positive Breast Cancer "PantHER".

Niamh M Keegan, Simon J Furney, Janice M Walshe, Giuseppe Gullo, M John Kennedy, Diarmuid Smith, John McCaffrey, Catherine M Kelly, Keith Egan, Jennifer Kerr and 16 more

Open access · goldAbstract read
In one paragraph

Article in Cancers, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.1field-weighted citation impact, top 20% 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

9 citing papers in PubMed, 19 citations in OpenAlex.

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  9. Breast Cancer Treatments: Updates and New Challenges.Journal of personalized medicine · 2021
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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

26 authors at 6 institutions in 1 country.

Niamh M KeeganDepartment of Molecular Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.
Simon J FurneyGenomic Oncology Research Group, Department of Physiology & Medical Physics, Centre for Systems Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.ORCID 0000-0002-8920-6800
Janice M WalsheDepartment of Medical Oncology, St Vincent's University Hospital, Dublin, Ireland.
Giuseppe GulloDepartment of Medical Oncology, St Vincent's University Hospital, Dublin, Ireland.
M John KennedyCancer Trials Ireland, Innovation House, Glasnevin, Dublin, Ireland.
Diarmuid SmithDepartment of Endocrinology, Beaumont Hospital, Dublin, Ireland.
John McCaffreyCancer Trials Ireland, Innovation House, Glasnevin, Dublin, Ireland.ORCID 0000-0002-0179-9067
Catherine M KellyCancer Trials Ireland, Innovation House, Glasnevin, Dublin, Ireland.
Keith EganCancer Clinical Trials & Research Unit, Beaumont Hospital, Dublin, Ireland.ORCID 0000-0002-4969-589X
Jennifer KerrDepartment of Radiology, Beaumont Hospital, Dublin, Ireland.
Mark GivenDepartment of Radiology, Beaumont Hospital, Dublin, Ireland.
Peter O'DonovanGenomic Oncology Research Group, Department of Physiology & Medical Physics, Centre for Systems Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.
Andres HernandoCancer Trials Ireland, Innovation House, Glasnevin, Dublin, Ireland.
Ausra TeiserskieneCancer Trials Ireland, Innovation House, Glasnevin, Dublin, Ireland.
Imelda ParkerCancer Trials Ireland, Innovation House, Glasnevin, Dublin, Ireland.
Elaine KayDepartment of Pathology, Beaumont Hospital, Dublin, Ireland.
Angela FarrellyDepartment of Molecular Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.ORCID 0000-0002-1242-5693
Aoife CarrDepartment of Molecular Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.
Giulio CalzaferriDepartment of Medical Oncology, St Vincent's University Hospital, Dublin, Ireland.
Ray McDermottDepartment of Medical Oncology, St Vincent's University Hospital, Dublin, Ireland.
Maccon M KeaneCancer Trials Ireland, Innovation House, Glasnevin, Dublin, Ireland.
Liam GroganDepartment of Medical Oncology, Beaumont Hospital, Dublin, Ireland.
Oscar BreathnachDepartment of Medical Oncology, Beaumont Hospital, Dublin, Ireland.
Patrick G MorrisDepartment of Medical Oncology, Beaumont Hospital, Dublin, Ireland.
Sinead ToomeyDepartment of Molecular Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.
Bryan T HennessyDepartment of Molecular Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.
Beaumont Hospital · IERoyal College of Surgeons in Ireland · IECancer Trials Ireland · IEMater Misericordiae University Hospital · IESt. Vincent's University Hospital · IEUniversity Hospital Galway · IE

Funding

Fox and Kerins Families N/AHealth Research Board ILP-POR-2019-006Irish Cancer Society CCRC13GALNorth East Cancer Research and Education Trust N/A
6 · The paper itself

Abstract

backgroundActivation of the phosphoinositide-3 kinase (PI3K) pathway is a resistance mechanism to anti-human epidermal growth factor receptor 2 (HER2) therapy. This phase Ib trial was conducted to determine the maximum tolerated dose (MTD) of copanlisib, an intravenous (IV) pan-class I PI3K inhibitor, combined with trastuzumab.

methodsPatients with advanced HER2-positive breast cancer and disease progression following at least one prior line of HER2 therapy in the metastatic setting were treated with copanlisib (45 or 60 mg) IV on days 1, 8 and 15 of a 28-day cycle with a fixed dose of trastuzumab 2 mg/kg weekly.

resultsTwelve patients were enrolled. The MTD was determined as copanlisib 60 mg plus trastuzumab 2 mg/kg weekly. The most common adverse events of any grade occurring in more than two patients were hyperglycaemia (58%), fatigue (58%), nausea (58%) and hypertension (50%). Stable disease was confirmed at 16 weeks in six participants (50%).

conclusionCopanlisib and trastuzumab can be safely administered with fair overall tolerability. Preliminary evidence of tumour stability was observed in patients with heavily pre-treated, metastatic HER2 positive breast cancer. Several potential biomarkers were identified for further study in the current phase 2 clinical trial. NCT: 02705859.

Indexed as

breast neoplasmscirculating tumour DNAhumanmaximum tolerated dosephosphoinositide-3 kinase (PI3K)PIK3CA proteintrastuzumab

Identifiers

PMID33799597
PMCPMC7999809
OpenAlexW3134174500

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.