Evidence map›Paper›PMID 39349477›Full record

ArticleNPJ breast cancer2024

Pharmacokinetics and pharmacogenomics of ribociclib in black patients with metastatic breast cancer the LEANORA study.

Ilana Schlam, D Max Smith, Cody Peer, Tristan Sissung, Keith T Schmidt, Ming Tan, Ami Chitalia, Nanette H Bishopric, Seth Steinberg, Hyoyoung Choo-Wosoba and 11 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in NPJ breast cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04657679 (evaLuation of Variations pharmacokinEtics and phArmacogeNOmics of Ribociclib in rAce-based Cohorts), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT04657679 phase4terminatednot on this map

evaLuation of Variations pharmacokinEtics and phArmacogeNOmics of Ribociclib in rAce-based Cohorts: The LEANORA Study

TypeinterventionalSponsorGeorgetown UniversityRan2021 to 2023Enrolled21ConditionsBreast CancerArmsRibociclib
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Ilana Schlam *Division of Hematology and Oncology, Tufts Medical Center, Boston, MA, USA.
D Max Smith *Department of Oncology, Georgetown University Medical Center, Washington, DC, USA.
Cody PeerClinical Pharmacology Program, National Cancer Institute, Bethesda, MD, USA.
Tristan SissungClinical Pharmacology Program, National Cancer Institute, Bethesda, MD, USA.
Keith T SchmidtClinical Pharmacology Program, National Cancer Institute, Bethesda, MD, USA.
Ming TanDepartment of Biostatistics, Bioinformatics and Biomathematics, Georgetown University Medical Center, Washington, DC, USA.
Ami ChitaliaHematology-Oncology Department, MedStar Washington Hospital Center, Washington, DC, USA.
Nanette H BishopricDepartment of Oncology, Georgetown University Medical Center, Washington, DC, USA.
Seth SteinbergOffice of Collaborative Biostatistics, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Hyoyoung Choo-WosobaOffice of Collaborative Biostatistics, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Giulia NapoliMolecular Pharmacology Section, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Christopher GallagherHematology-Oncology Department, MedStar Washington Hospital Center, Washington, DC, USA.ORCID http://orcid.org/0000-0002-3846-5052
Nadia AshaiGeorgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.
Kristen WhitakerHematology-Oncology Department, MedStar Washington Hospital Center, Washington, DC, USA.
Candace MainorGeorgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.
Shruti TiwariVirginia Cancer Specialists, Fairfax, VA, USA.
Nicole SwansonDepartment of Oncology, Georgetown University Medical Center, Washington, DC, USA.
Stacy MalloyHematology-Oncology Department, MedStar Washington Hospital Center, Washington, DC, USA.
Claudine IsaacsDepartment of Oncology, Georgetown University Medical Center, Washington, DC, USA.ORCID http://orcid.org/0000-0002-9646-1260
William Douglas FiggClinical Pharmacology Program, National Cancer Institute, Bethesda, MD, USA.
Sandra M SwainMedStar Health, Columbia, MD, USA. sms248@georgetown.edu.ORCID http://orcid.org/0000-0002-1320-3830

Funding

Tissue Culture Shared ResourceP30CA051008 · NCI · GEORGETOWN UNIVERSITY · PI MARCUS S NOEL · 1990 to 2026
$71.5M
Georgetown-Howard Universities Center for Clinical and Translational Science (GHUUL1TR000101 · NCATS · GEORGETOWN UNIVERSITY · PI MELLMAN, THOMAS A, VERBALIS, JOSEPH G · 2012 to 2015
$19.3M
Georgetown-Howard Universities Center for Clinical and Translational Science (GHUUL1RR031975 · NCRR · GEORGETOWN UNIVERSITY · PI MELLMAN, THOMAS A, VERBALIS, JOSEPH G · 2010 to 2011
$14.6M
Breast Cancer Research Foundation (BCRF) BCRF-20-156Conquer Cancer Foundation (Conquer Cancer Foundation of the American Society of Clinical Oncology) ASCO Young Investigator Award (PI)NCATS NIH HHS UL1 TR000101NCI NIH HHS P30 CA051008NCRR NIH HHS UL1 RR031975U.S. Department of Health & Human Services | NIH | National Center for Advancing Translational Sciences (NCATS) Core grant (P30CA051008), Grant # UL1TR000101 (previously UL1RR031975)
6 · The paper itself

Abstract

Underrepresented populations' participation in clinical trials remains limited, and the potential impact of genomic variants on drug metabolism remains elusive. This study aimed to assess the pharmacokinetics (PK) and pharmacogenomics (PGx) of ribociclib in self-identified Black women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2) advanced breast cancer. LEANORA (NCT04657679) was a prospective, observational, multicenter cohort study involving 14 Black women. PK and PGx were evaluated using tandem mass spectrometry and PharmacoScan™ microarray (including CYP3A5*3, *6, and *7). CYP3A5 phenotypes varied among participants: 7 poor metabolizers (PM), 6 intermediate metabolizers (IM), and one normal metabolizer (NM). The area under the curve did not significantly differ between PMs (39,230 h*ng/mL) and IM/NMs (43,546 h*ng/mL; p = 0.38). The incidence of adverse events (AEs) was also similar. We found no association between CYP3A5 genotype and ribociclib exposure. Continued efforts are needed to include diverse populations in clinical trials to ensure equitable treatment outcomes.

Identifiers

PMID39349477
PMCPMC11442496

What Socratic 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 Socratic graph.