Evidence map›Paper›PMID 27133732›Full record

Trial reportClinical breast cancer2016

Targeting Estrogen Receptor Beta in a Phase 2 Study of High-Dose Estradiol in Metastatic Triple-Negative Breast Cancer: A Wisconsin Oncology Network Study.

Kari B Wisinski, Wei Xu, Amye J Tevaarwerk, Sandeep Saha, KyungMann Kim, Anne Traynor, Leah Dietrich, Robert Hegeman, Dhimant Patel, Jules Blank and 2 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical breast cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
3.0field-weighted citation impact, top 9% 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

14 citing papers in PubMed, 46 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Drivers and suppressors of triple-negative breast cancer.Proceedings of the National Academy of Sciences of the United States of America · 2021
    Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Article
  13. Genistein PreventsCurrent developments in nutrition · 2017
    Article
  14. Review
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

12 authors at 4 institutions in 1 country.

Kari B WisinskiCarbone Cancer Center, University of Wisconsin, Madison, WI; School of Medicine and Public Health, University of Wisconsin, Madison, WI. Electronic address: kbwisinski@medicine.wisc.edu.
Wei XuCarbone Cancer Center, University of Wisconsin, Madison, WI; McArdle Laboratory for Cancer Research, University of Wisconsin, Madison, WI.
Amye J TevaarwerkCarbone Cancer Center, University of Wisconsin, Madison, WI; School of Medicine and Public Health, University of Wisconsin, Madison, WI.
Sandeep SahaDepartment of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI.
KyungMann KimCarbone Cancer Center, University of Wisconsin, Madison, WI; Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI.
Anne TraynorCarbone Cancer Center, University of Wisconsin, Madison, WI; School of Medicine and Public Health, University of Wisconsin, Madison, WI.
Leah DietrichGundersen Lutheran Health System, Lacrosse, WI.
Robert HegemanCarbone Cancer Center, University of Wisconsin, Madison, WI; School of Medicine and Public Health, University of Wisconsin, Madison, WI.
Dhimant PatelVince Lombardi Cancer Clinic, Aurora HealthCare Network, Green Bay, WI.
Jules BlankSt Vincent Regional Cancer Center, Green Bay, WI.
Josephine HarterCarbone Cancer Center, University of Wisconsin, Madison, WI; Department of Pathology and Laboratory Medicine, University of Wisconsin, Madison, WI.
Mark E BurkardCarbone Cancer Center, University of Wisconsin, Madison, WI; School of Medicine and Public Health, University of Wisconsin, Madison, WI.
University of Wisconsin–Madison · USAurora Health Care · USGundersen Health System · USSaint Vincent Health System · US

Funding

UW COMPREHENSIVE CANCER CENTER SUPPORTP30CA014520 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI Christian Capitini · 1985 to 2026
$142.6M
Viral VectorP30CA086862 · NCI · UNIVERSITY OF IOWA · PI Christopher K Laubenthal · 2000 to 2026
$70.0M
Institutional Clinical and Translational Science AwardUL1TR000427 · NCATS · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2012 to 2016
$32.2M
Institutional Clinical and Translational Science AwardKL2TR000428 · NCATS · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2012 to 2016
$6.2M
PLANNING AND EVALUATIONP20CA103697 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI WEINDRUCH, RICHARD · 2003 to 2007
$3.0M
NCATS NIH HHS KL2 TR000428NCATS NIH HHS UL1 TR000427NCI NIH HHS P20 CA103697NCI NIH HHS P30 CA014520NCI NIH HHS P30 CA086862
6 · The paper itself

Abstract

backgroundEstrogen receptor beta (ERβ) is expressed by 50% to 80% of triple-negative breast cancers (TNBC). Agonism of ERβ has antiproliferative effects in TNBC cells expressing ERβ. This phase 2 study evaluated single-agent high-dose estradiol in patients with advanced TNBC. PATIENTS AND

methodsAdult women with measurable advanced TNBC were treated with estradiol 10 mg oral 3 times daily provided continuously for 28-day cycles. A Simon optimal 2-stage design was used. The primary end point was objective response (OR). Secondary end points included progression-free survival (PFS), clinical benefit (CB), and safety. OR, CB, and PFS by ERβ status were also examined.

resultsSeventeen evaluable women were enrolled. Median age was 58 years (range, 34-90 years); the median number of prior systemic therapies was 2 (range, 0-6). One patient had a confirmed partial response (OR rate, 5.9%) and remained on the study for > 24 weeks. Three patients had stable disease, with one lasting more than 16 weeks. ERβ expression was detected in 77% (13 patients). The CB rate at 16 weeks was 15% (2 of 13) in ERβ-positive patients and 0% (0 of 4) in ERβ-negative patients (P = 1). PFS was poor (median, 1.9 months) and not statistically significantly different between ERβ-positive versus -negative patients. No new adverse events from estradiol were identified. The study closed after the first stage as a result of limited responses in these unselected patients.

conclusionIn unselected TNBC, high-dose estradiol has limited efficacy. However, further evaluation of ERβ selective agonists in TNBC selected by ERβ expression may be warranted.

Indexed as

Molecular Targeted TherapyAdministration, OralAdultAgedAged, 80 and overDisease-Free SurvivalDrug Administration ScheduleEarly Termination of Clinical TrialsEstradiolEstrogen Receptor betaEstrogensFemaleHumansMiddle AgedNeoplasm StagingProspective StudiesESR2 protein, humanEstradiolEstrogen Receptor betaEstrogensEstradiolEstrogen receptor betaTriple-negative breast cancer

Identifiers

PMID27133732
PMCPMC4969205
OpenAlexW2312430376

What OpenQuestion holds

Textmetadata
LicenceTDM
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.