Evidence map›Paper›PMID 34504990›Full record

Trial reportJCO precision oncology2021

Genomic Profiling of Premenopausal HR+ and HER2- Metastatic Breast Cancer by Circulating Tumor DNA and Association of Genetic Alterations With Therapeutic Response to Endocrine Therapy and Ribociclib.

Aditya Bardia, Fei Su, Nadia Solovieff, Seock-Ah Im, Joohyuk Sohn, Keun Seok Lee, Saul Campos-Gomez, Kyung Hae Jung, Marco Colleoni, Rafael Villanueva Vázquez and 9 more

Erratum issuedOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JCO precision oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 6% 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

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. A Phase II Study of Fulvestrant plus Abemaciclib in Hormone Receptor-Positive Advanced or Recurrent Endometrial Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Serial analysis ofFrontiers in oncology · 2025
    Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Seize the engine: Emerging cell cycle targets in breast cancer.Clinical and translational medicine · 2024
    Review
  17. Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 15 institutions in 9 countries.

Aditya BardiaMassachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA.
Fei SuNovartis Pharmaceuticals Corporation, East Hanover, NJ.
Nadia SolovieffNovartis Pharmaceuticals Corporation, Cambridge, MA.
Seock-Ah ImSeoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.
Joohyuk SohnYonsei Cancer Center, Yonsei University Health System, Seoul, South Korea.
Keun Seok LeeCenter for Breast Cancer, National Cancer Center, Goyang, South Korea.
Saul Campos-GomezCentro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico.
Kyung Hae JungAsan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Marco ColleoniDivision of Medical Senology, IEO, European Institute of Oncology, IRCCS, Milan, Italy.
Rafael Villanueva VázquezInstitut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain.
Fabio FrankeHospital de Caridade de Ijuí, CACON, Ijuí, Brazil.
Sara HurvitzUniversity of California, Los Angeles Jonsson Comprehensive Cancer Center, Los Angeles, CA.
Nadia HarbeckDepartment of Obstetrics and Gynecology, Breast Center, Ludwig-Maximilians-University Munich, Munich, Germany.
Louis ChowOrganisation for Oncology and Translational Research, Hong Kong, China.
Tetiana TaranNovartis Pharmaceuticals Corporation, East Hanover, NJ.
Karen Rodriguez LorencNovartis Pharmaceuticals Corporation, East Hanover, NJ.
Naveen BabbarNovartis Pharmaceuticals Corporation, Cambridge, MA.
Debu TripathyThe University of Texas MD Anderson Cancer Center, Houston, TX.
Yen-Shen LuNational Taiwan University Hospital, Taipei, Taiwan.
Novartis (United States) · USHarvard University · USHospital Universitário Cajuru · BRInstitut Català d'Oncologia · ESInstituto de Salud del Estado de México · MXIstituti di Ricovero e Cura a Carattere Scientifico · ITLudwig-Maximilians-Universität München · DENational Cancer Center · KRNational Taiwan University Hospital · TWSeoul National University Hospital · KRThe University of Texas MD Anderson Cancer Center · USUlsan College · KRUnimed Medical Institute · CNUniversity of California, Los Angeles · USYonsei University Health System · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis analysis evaluated the genomic landscape of premenopausal patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer and the association of genetic alterations with response to ribociclib in the phase III MONALEESA-7 trial.

methodsPremenopausal patients were randomly assigned 1:1 to receive endocrine therapy plus ribociclib or placebo. Plasma collected at baseline was sequenced using targeted next-generation sequencing for approximately 600 relevant cancer genes. The association of circulating tumor DNA alterations with progression-free survival (PFS) was evaluated to identify biomarkers of response and resistance to ribociclib.

resultsBaseline circulating tumor DNA was sequenced in 565 patients; 489 had evidence of ≥ 1 alteration. The most frequent alterations included

conclusionIn this study-to our knowledge, the first large study of premenopausal patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer-multiple genomic alterations were associated with poor outcome. A PFS benefit of ribociclib was observed regardless of gene alteration status, although in this exploratory analysis, a magnitude of benefits varied by alteration.

Indexed as

AdolescentAdultAminopyridinesAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCirculating Tumor DNADouble-Blind MethodDrug Resistance, NeoplasmErb-b2 Receptor Tyrosine KinasesFemaleGenomicsHumansMiddle AgedPremenopauseAminopyridinesAntineoplastic Agents, HormonalBiomarkers, TumorCirculating Tumor DNAERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesHR protein, humanPurinesribociclibTranscription Factors

Identifiers

PMID34504990
PMCPMC8423397
OpenAlexW3197298803

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.