Evidence map›Paper›PMID 30400780›Full record

Trial reportBMC cancer2018

Ixazomib in combination with carboplatin in pretreated women with advanced triple-negative breast cancer, a phase I/II trial of the AGMT (AGMT MBC-10 trial).

Gabriel Rinnerthaler, Simon Peter Gampenrieder, Andreas Petzer, Sonja Burgstaller, David Fuchs, Dieter Rossmann, Marija Balic, Daniel Egle, Holger Rumpold, Christian F Singer and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02993094 (Ixazomib), which is not on this 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 21% 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.

NCT02993094 phase1 / phase2terminatednot on this map

Ixazomib (MLN9708) in Combination With Carboplatin in Pretreated Women With Advanced Triple Negative Breast Cancer

TypeinterventionalSponsorArbeitsgemeinschaft medikamentoese TumortherapieRan2016 to 2020Enrolled31ConditionsTriple-Negative Breast CancerArmsIxazomib, Carboplatin
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 15 citations in OpenAlex.

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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

16 authors at 10 institutions in 1 country.

Gabriel RinnerthalerIIIrd Medical Department with Hematology and Medical Oncology, Hemostaseology, Rheumatology and Infectious Diseases, Oncologic Center, Paracelsus Medical University Salzburg, Müllner Hauptstrasse 48, 5020, Salzburg, Austria.
Simon Peter GampenriederIIIrd Medical Department with Hematology and Medical Oncology, Hemostaseology, Rheumatology and Infectious Diseases, Oncologic Center, Paracelsus Medical University Salzburg, Müllner Hauptstrasse 48, 5020, Salzburg, Austria.
Andreas PetzerInternal Department I for Medical Oncology and Hematology, Ordensklinikum Linz Barmherzige Schwestern, Linz, Austria.
Sonja BurgstallerIVth Department of Internal Medicine with Hematology and Medical Oncolocy, Klinikum Wels-Grieskirchen, Wels, Austria.
David FuchsDepartment of Internal Medicine 3 - Hematology and Oncology, Kepler University Hospital, Linz, Austria.
Dieter Rossmann2nd Medical Department, County Hospital Steyr, Steyr, Austria.
Marija BalicDivision of Oncology, Department of Internal Medicine, Medical University Graz, Graz, Austria.
Daniel EgleDepartment of Obstetrics and Gynaecology, Innsbruck Medical University, Innsbruck, Austria.
Holger RumpoldDepartment of Oncology, Hematology and Gastroenterology, Academic Teaching Hospital Feldkirch, Feldkirch, Austria.
Christian F SingerDepartment of Obstetrics and Gynecology, Cancer Comprehensive Center, Medical University of Vienna, Vienna, Austria.
Rupert BartschDepartment of Internal Medicine 1, Division of Oncology, Cancer Comprehensive Center, Medical University of Vienna, Vienna, Austria.
Edgar PetruDepartment of Obstetrics and Gynaecology, Clinical Department of Gynecology, Medical University Graz, Graz, Austria.
Thomas MelchardtIIIrd Medical Department with Hematology and Medical Oncology, Hemostaseology, Rheumatology and Infectious Diseases, Oncologic Center, Paracelsus Medical University Salzburg, Müllner Hauptstrasse 48, 5020, Salzburg, Austria.
Hanno UlmerDepartment of Medical Statistics and Informatics, Medical University Innsbruck, Innsbruck, Austria.
Brigitte MlineritschIIIrd Medical Department with Hematology and Medical Oncology, Hemostaseology, Rheumatology and Infectious Diseases, Oncologic Center, Paracelsus Medical University Salzburg, Müllner Hauptstrasse 48, 5020, Salzburg, Austria.
Richard GreilIIIrd Medical Department with Hematology and Medical Oncology, Hemostaseology, Rheumatology and Infectious Diseases, Oncologic Center, Paracelsus Medical University Salzburg, Müllner Hauptstrasse 48, 5020, Salzburg, Austria. r.greil@salk.at.
Paracelsus Medical University · ATInnsbruck Medical University · ATMedical University of Graz · ATComprehensive Cancer Center Vienna · ATKepler Universitätsklinikum · ATKlinikum Wels-Grieskirchen · ATLandeskrankenhaus Feldkirch · ATMedical University of Vienna · ATOrdensklinikum Linz Barmherzige Schwestern · ATUniversity of Salzburg · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTriple-negative breast cancer (TNBC) comprises a heterogeneous group of diseases which are generally associated with poor prognosis. Up to now, no targeted treatment beyond anti-VEGF therapy has been approved for TNBC and cytotoxic agents remain the mainstay of treatment. Ixazomib is a selective and reversible inhibitor of the proteasome, which has been mainly investigated in the treatment of multiple myeloma. In a preclinical study TNBC cells were treated with the first-generation proteasome inhibitor bortezomib in combination with cisplatin and synergistic efficacy was demonstrated. Clinical data are available for carboplatin plus bortezomib in metastatic ovarian and lung cancers showing remarkable antitumor activity and good tolerability (Mol Cancer 11:26 2012, J Thorac Oncol 4:87-92 2009, J Thorac Oncol 7:1032-1040, 2012). Based on this evidence, the phase I/II MBC-10 trial will evaluate the toxicity profile and efficacy of the second-generation proteasome inhibitor ixazomib in combination with carboplatin in patients with advanced TNBC.

methodsPatients with metastatic TNBC pretreated with at least one prior line of chemotherapy for advanced disease with a confirmed disease progression and measurable disease according to RECIST criteria 1.1 are eligible for this study. Patients will receive ixazomib in combination with carboplatin on days 1, 8, and 15 in a 28-day cycle. The phase I part of this study utilizes an alternate dose escalation accelerated titration design. After establishing the maximum tolerated dose (MTD), the efficacy and safety of the combination will be further evaluated (phase II, including 41 evaluable patients). All patients will continue on study drugs until disease progression, unacceptable toxicity or discontinuation for any other reason. Primary endpoint of the phase II is overall response rate, secondary endpoints include progression-free survival, safety, and quality of life. This trial is open for patient enrollment since November 2016 in six Austrian cancer centers. Accrual is planned to be completed within 2 years. DISCUSSION: Based on preclinical and clinical findings an ixazomib and carboplatin combination is thought to be effective in metastatic TNBC patients. The MBC-10 trial is accompanied by a broad biomarker program investigating predictive biomarkers for treatment response and potential resistance mechanisms to the investigational drug combination.

trial registrationEudraCT Number: 2016-001421-13 received on March 31, 2016, ClinicalTrials.gov Identifier: NCT02993094 first posted on December 15, 2016. This trial was registered prospectively.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsAustriaBoron CompoundsBortezomibCarboplatinDose-Response Relationship, DrugFemaleGlycineHumansMaximum Tolerated DoseMiddle AgedNeoplasm MetastasisNeoplasm StagingProgression-Free SurvivalBoron CompoundsBortezomibCarboplatinGlycineixazomibBreast cancerCarboplatinIxazomibPlatinumProteasome inhibitorTriple-negative

Identifiers

PMID30400780
PMCPMC6220453
OpenAlexW2899626130

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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.