Evidence map›Paper›PMID 33513026›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Phase I Study of Elacestrant (RAD1901), a Novel Selective Estrogen Receptor Degrader, in ER-Positive, HER2-Negative Advanced Breast Cancer.

Aditya Bardia, Virginia Kaklamani, Sharon Wilks, Amy Weise, Donald Richards, Wael Harb, Cynthia Osborne, Robert Wesolowski, Meghan Karuturi, Paul Conkling and 4 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 63 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 1 pooled it
13.6field-weighted citation impact, top 1% 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.

NCT02338349 phase1completednot on this map

A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer

TypeinterventionalSponsorStemline Therapeutics, Inc.Ran2015 to 2020Enrolled57ConditionsAdvanced ER+, HER2-Negative Breast CancerArmsElacestrant
NCT06201234 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Phase II Study Evaluating the Addition of Elacestrant, an Oral Selective Estrogen Receptor Degrader (SERD), to Standard-of-care Olaparib in Patients With Hormone Receptor (HR)-Positive, HER2-negative Locally Advanced or Metastatic Breast Cancer With gBRCA1/2 Mutations

TypeinterventionalSponsorGBG Forschungs GmbHRan2024 to 2028Enrolled176ConditionsHormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer, BRCA1 Mutation, BRCA2 MutationArmsOlaparib + Elacestrant, Olaparib
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 1 synthesis or guideline pooled it, 107 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative,Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Trial
  5. Trial
  6. Trial
  7. Review
  8. Targeting Estrogen Receptor for Breast Cancer.Current issues in molecular biology · 2026
    Review
  9. Article
  10. Observational
  11. Review
  12. ER degradation for ERNature communications · 2025
    Article
  13. Review
  14. Article
  15. Article
  16. Breast cancer: pathogenesis and treatments.Signal transduction and targeted therapy · 2025
    Review
  17. Review
  18. Article
  19. Review
  20. Review

3 more citing papers are in PubMed but not listed here.

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

14 authors at 10 institutions in 1 country.

Aditya BardiaMassachusetts General Hospital Cancer Center, Boston, MA.ORCID 0000-0003-4885-1157
Virginia KaklamaniUniversity of Texas Health Sciences Center, Houston, TX.ORCID 0000-0002-3313-8458
Sharon WilksTexas Oncology-San Antonio, San Antonio, TX.
Amy WeiseBarbara Ann Karmanos Cancer Center, Detroit, MI.
Donald RichardsTexas Oncology-Tyler, Tyler, TX.
Wael HarbHorizon Oncology Center, Lafayette, IN.
Cynthia OsborneTexas Oncology-Baylor Charles A. Sammons Cancer Center; Dallas, TX.
Robert WesolowskiOhio State University Comprehensive Cancer Center, Columbus, OH.ORCID 0000-0003-0606-0648
Meghan KaruturiMD Anderson Cancer Center, Houston, TX.
Paul ConklingUS Oncology Research, Virginia Oncology Associates, Norfolk, VA.
Rebecca G BagleyRadius Health, Inc., Waltham, MA.
Yamei WangRadius Health, Inc., Waltham, MA.ORCID 0000-0002-5741-9836
Maureen G ConlanRadius Health, Inc., Waltham, MA.
Peter KabosUniversity of Colorado, Aurora, CO.ORCID 0000-0003-1500-471X
Radius Health (United States) · USTexas Oncology · USHorizon Oncology Center · USMassachusetts General Hospital · USThe Barbara Ann Karmanos Cancer Institute · USThe Ohio State University · USThe University of Texas Health Science Center at Houston · USThe University of Texas MD Anderson Cancer Center · USUniversity of Colorado Anschutz Medical Campus · USVirginia Oncology Associates · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis phase I study (RAD1901-005; NCT02338349) evaluated elacestrant, an investigational oral selective estrogen receptor degrader (SERD), in heavily pretreated women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer, including those with estrogen receptor gene alpha (

methodsThe study consisted of a 3 + 3 design (elacestrant capsules) followed by expansion at RP2D (400-mg capsules, then 400-mg tablets) for the evaluation of safety and antitumor activity. Elacestrant was taken once daily until progression or intolerability.

resultsOf 57 postmenopausal women enrolled, 50 received RP2D (400 mg once daily): median age, 63 years; median three prior anticancer therapies, including cyclin-dependent kinase 4,6 inhibitors (CDK4/6i; 52%), SERD (52%), and

conclusionElacestrant 400 mg orally once daily has an acceptable safety profile and demonstrated single-agent activity with confirmed partial responses in heavily pretreated patients with estrogen receptor-positive metastatic breast cancer. Notably, responses were observed in patients with

Indexed as

AdultAgedAged, 80 and overBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesEstrogen Receptor alphaFemaleHumansMiddle AgedMutationReceptors, EstrogenTetrahydronaphthaleneselacestrantERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesESR1 protein, humanEstrogen Receptor alphaReceptors, EstrogenTetrahydronaphthalenes

Identifiers

PMID33513026
PMCPMC8078341
OpenAlexW3123867938

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.