Evidence map›Paper›PMID 31849202›Full record

Trial reportCancer medicine2020

Phase II study of Radium-223 dichloride combined with hormonal therapy for hormone receptor-positive, bone-dominant metastatic breast cancer.

Naoto T Ueno, Rie K Tahara, Takeo Fujii, James M Reuben, Hui Gao, Babita Saigal, Anthony Lucci, Toshiaki Iwase, Nuhad K Ibrahim, Senthil Damodaran and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02366130 (Phase II Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 10% 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.

NCT02366130 phase2completednot on this map

Phase II Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2015 to 2020Enrolled45ConditionsBreast CancerArmsRa-223 dichloride, Denosumab, Hormone Therapy
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
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  6. Dissecting the effects ofActa pharmaceutica Sinica. B · 2025
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  14. Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2022
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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 1 institution in 1 country.

Naoto T UenoDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-0166-7275
Rie K TaharaDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Takeo FujiiDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
James M ReubenDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Hui GaoDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Babita SaigalDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Anthony LucciDepartment of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Toshiaki IwaseDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nuhad K IbrahimDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Senthil DamodaranDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Yu ShenDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Diane D LiuDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Gabriel N HortobagyiDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Debu TripathyDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Bora LimDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Beth A ChasenDepartment of Nuclear Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
Convalescent Plasma to Limit Coronavirus Associated ComplicationsUL1TR003167 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI KARP, DANIEL D, MCPHERSON, DAVID D · 2019 to 2023
$45.3M
NCATS NIH HHS UL1 TR003167NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundRadium-223 dichloride (Ra-223) is a targeted alpha therapy that induces localized cytotoxicity in bone metastases. We evaluated the efficacy and safety of Ra-223 plus hormonal therapy in hormone receptor-positive (HR+), bone-dominant metastatic breast cancer.

methodsIn this single-center phase II study, 36 patients received Ra-223 (55 kBq/kg intravenously every 4 weeks) up to 6 cycles with endocrine therapy. The primary objective was to determine the clinical disease control rate at 9 months. Secondary objectives were to determine (a) tumor response rate at 6 months, (b) progression-free survival (PFS) durations, and (c) safety.

resultsThe median number of prior systemic treatments for metastatic disease was 1 (range, 0-4). The disease control rate at 9 months was 49%. The tumor response rate at 6 months was 54% (complete response, 21%; partial, 32%). The median PFS was 7.4 months (95% CI, 4.8-not reached [NR]). The median bone-PFS was 16 months (95% CI, 7.3-NR). There were no grade 3/4 adverse events.

conclusionsRa-223 with hormonal therapy showed possible efficacy in HR+ bone-dominant breast cancer metastasis, and adverse events were tolerable. We plan to further investigate the clinical application of Ra-223 in these patients. (NCT02366130).

Indexed as

AdultAgedAlpha ParticlesAntineoplastic Agents, HormonalBone and BonesBone NeoplasmsBreastBreast NeoplasmsChemoradiotherapyDenosumabFemaleFulvestrantHumansInjections, IntravenousMiddle AgedPositron Emission Tomography Computed TomographyAntineoplastic Agents, HormonalDenosumabFulvestrantRadioisotopesRadiumradium Ra 223 dichlorideReceptors, EstrogenReceptors, ProgesteroneTamoxifenalphatherapybone metastasisbreast cancerhormonal therapyhormone receptor-positiveRadium-223 dichloride

Identifiers

PMID31849202
PMCPMC6997080
OpenAlexW2994644550

What OpenQuestion holds

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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.