Evidence mapPaperPMID 25991817Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2015

Efficacy of SERD/SERM Hybrid-CDK4/6 Inhibitor Combinations in Models of Endocrine Therapy-Resistant Breast Cancer.

Suzanne E Wardell, Matthew J Ellis, Holly M Alley, Koleen Eisele, Todd VanArsdale, Stephen G Dann, Kim T Arndt, Tina Primeau, Elizabeth Griffin, Jieya Shao and 5 more

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03820830 (A Phase III Open-label, Multicenter, Randomized Trial of Adjuvant Palbociclib in Combination With Endocrine Therapy Versus Endocrine Therapy Alone for Patients With Hormone Receptor Positive / HER2-negative Resected Isolated Locoregional Recurrence of Breast Cancer), which is not on this map. Cited by 95 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing 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.

NCT03820830 phase3active not recruitingnot on this mapstarted 2019, after this paper: background citation

A Phase III Open-label, Multicenter, Randomized Trial of Adjuvant Palbociclib in Combination With Endocrine Therapy Versus Endocrine Therapy Alone for Patients With Hormone Receptor Positive / HER2-negative Resected Isolated Locoregional Recurrence of Breast Cancer

TypeinterventionalSponsorETOP IBCSG Partners FoundationRan2019 to 2029Enrolled405ConditionsBreast Cancer RecurrentArmsPalbociclib 125mg, Standard endocrine therapy
3 · Its place in the literature

Who cites it

95 citing papers in PubMed, 1 synthesis or guideline pooled it, 159 citations in OpenAlex.

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  11. ESR1 Y537S and D538G Mutations Drive Resistance to CDK4/6 Inhibitors in Estrogen Receptor-Positive Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
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35 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 7 institutions in 2 countries.

Suzanne E Wardell *Department of Pharmacology and Cancer Biology Duke University School of Medicine Durham, NC 27710.
Matthew J Ellis *Lester and Sue Smith Breast Center, Baylor College of Medicine Houston TX 77030.
Holly M AlleyDepartment of Pharmacology and Cancer Biology Duke University School of Medicine Durham, NC 27710.
Koleen EiselePfizer Oncology Research Unit La Jolla, CA 92121.
Todd VanArsdalePfizer Oncology Research Unit La Jolla, CA 92121.
Stephen G DannPfizer Oncology Research Unit La Jolla, CA 92121.
Kim T ArndtPfizer Oncology Research Unit Pearl River, NY 10965.
Tina PrimeauDivision of Oncology, Department of Internal Medicine Washington University in St Louis, MO 63110.
Elizabeth GriffinDivision of Oncology, Department of Internal Medicine Washington University in St Louis, MO 63110.
Jieya ShaoDivision of Oncology, Department of Internal Medicine Washington University in St Louis, MO 63110.
Robert CrowderDivision of Oncology, Department of Internal Medicine Washington University in St Louis, MO 63110.
Jin-Ping LaiDepartment of Pathology Saint Louis University, MO 63104.
John D NorrisDepartment of Pharmacology and Cancer Biology Duke University School of Medicine Durham, NC 27710.
Donald P McDonnellDepartment of Pharmacology and Cancer Biology Duke University School of Medicine Durham, NC 27710.
Shunqiang LiDivision of Oncology, Department of Internal Medicine Washington University in St Louis, MO 63110.
Duke University · USWashington University in St. Louis · USLa Jolla Alcohol Research · USBaylor College of Medicine · USBreast Cancer Research Foundation · USPearl River Community College · USSaint Louis University · ES

Funding

Washington University Center for Cellular ImagingP30CA091842 · WASHINGTON UNIVERSITY · 2001 to 2025
$19.4M
MECHANISM OF ESTROGENS AND ANTIESTROGENSR01DK048807 · DUKE UNIVERSITY · 1995 to 2004
$1.7M
Mechanism of Action of Estrogens and AntiestrogensR37DK048807 · DUKE UNIVERSITY · 2005 to 2005
$457k
NCI NIH HHS NCI P30 CA91842NCI NIH HHS P30 CA091842NCRR NIH HHS 5UL1RR02499203NIDDK NIH HHS 2R01DK048807NIDDK NIH HHS R01 DK048807NIDDK NIH HHS R37 DK048807
6 · The paper itself

Abstract

purposeEndocrine therapy, using tamoxifen or an aromatase inhibitor, remains first-line therapy for the management of estrogen receptor (ESR1)-positive breast cancer. However, ESR1 mutations or other ligand-independent ESR1 activation mechanisms limit the duration of response. The clinical efficacy of fulvestrant, a selective estrogen receptor downregulator (SERD) that competitively inhibits agonist binding to ESR1 and triggers receptor downregulation, has confirmed that ESR1 frequently remains engaged in endocrine therapy-resistant cancers. We evaluated the activity of a new class of selective estrogen receptor modulators (SERM)/SERD hybrids (SSH) that downregulate ESR1 in relevant models of endocrine-resistant breast cancer. Building on the observation that concurrent inhibition of ESR1 and the cyclin-dependent kinases 4 and 6 (CDK4/6) significantly increased progression-free survival in advanced patients, we explored the activity of different SERD- or SSH-CDK4/6 inhibitor combinations in models of endocrine therapy-resistant ESR1(+) breast cancer. EXPERIMENTAL

designSERDs, SSHs, and the CDK4/6 inhibitor palbociclib were evaluated as single agents or in combination in established cellular and animal models of endocrine therapy-resistant ESR1(+) breast cancer.

resultsThe combination of palbociclib with a SERD or an SSH was shown to effectively inhibit the growth of MCF7 cell or ESR1-mutant patient-derived tumor xenografts. In tamoxifen-resistant MCF7 xenografts, the palbociclib/SERD or SSH combination resulted in an increased duration of response as compared with either drug alone.

conclusionsA SERD- or SSH-palbociclib combination has therapeutic potential in breast tumors resistant to endocrine therapies or those expressing ESR1 mutations. See related commentary by DeMichele and Chodosh, p. 4999.

Indexed as

AnimalsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6Disease-Free SurvivalDrug Resistance, NeoplasmEstradiolEstrogen Receptor alphaFemaleFulvestrantGene Expression Regulation, NeoplasticHumansMCF-7 CellsMiceAntineoplastic Agents, HormonalCDK4 protein, humanCDK6 protein, humanCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6ESR1 protein, humanEstradiolEstrogen Receptor alphaFulvestrantpalbociclibPiperazinesPyridinesSelective Estrogen Receptor ModulatorsTamoxifen

Identifiers

PMID25991817
PMCPMC4644714
OpenAlexW2135944809

What Socratic holds

Textmetadata
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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.