Evidence map›Paper›PMID 27287781›Full record

Trial reportBreast cancer research and treatment2016

Phase I biomarker modulation study of atorvastatin in women at increased risk for breast cancer.

Banu K Arun, Yun Gong, Diane Liu, Jennifer K Litton, Angelica M Gutierrez-Barrera, J Jack Lee, Lana Vornik, Nuhad K Ibrahim, Terri Cornelison, Gabriel N Hortobagyi and 8 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
0.9field-weighted citation impact, top 27% 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

13 citing papers in PubMed, 36 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. Statins: a role in breast cancer therapy?Journal of internal medicine · 2018
    Review
  12. Use of Receiver Operating Characteristic (ROC) Curve Analysis for Tyrer-Cuzick and Gail in Breast Cancer Screening in Jiangxi Province, China.Medical science monitor : international medical journal of experimental and clinical research · 2018
    Article
  13. 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

18 authors at 3 institutions in 1 country.

Banu K ArunBreast Medical Oncology and Clinical Cancer Genetics, The University of Texas MD Anderson Cancer Center, 1155 Pressler Street, CPB 5., Box 1354, Houston, TX, 77030, USA. barun@mdanderson.org.
Yun GongBreast Medical Oncology and Clinical Cancer Genetics, The University of Texas MD Anderson Cancer Center, 1155 Pressler Street, CPB 5., Box 1354, Houston, TX, 77030, USA.
Diane LiuDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jennifer K LittonBreast Medical Oncology and Clinical Cancer Genetics, The University of Texas MD Anderson Cancer Center, 1155 Pressler Street, CPB 5., Box 1354, Houston, TX, 77030, USA.
Angelica M Gutierrez-BarreraBreast Medical Oncology and Clinical Cancer Genetics, The University of Texas MD Anderson Cancer Center, 1155 Pressler Street, CPB 5., Box 1354, Houston, TX, 77030, USA.
J Jack LeeDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Lana VornikClinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nuhad K IbrahimBreast Medical Oncology and Clinical Cancer Genetics, The University of Texas MD Anderson Cancer Center, 1155 Pressler Street, CPB 5., Box 1354, Houston, TX, 77030, USA.
Terri CornelisonDivision of Cancer Prevention, National Cancer Institute, Rockville, MD, USA.
Gabriel N HortobagyiBreast Medical Oncology and Clinical Cancer Genetics, The University of Texas MD Anderson Cancer Center, 1155 Pressler Street, CPB 5., Box 1354, Houston, TX, 77030, USA.
Brandy M Heckman-StoddardDivision of Cancer Prevention, National Cancer Institute, Rockville, MD, USA.
Kimberly B KoenigBreast Medical Oncology and Clinical Cancer Genetics, The University of Texas MD Anderson Cancer Center, 1155 Pressler Street, CPB 5., Box 1354, Houston, TX, 77030, USA.
Ricardo R AlvarezBreast Medical Oncology and Clinical Cancer Genetics, The University of Texas MD Anderson Cancer Center, 1155 Pressler Street, CPB 5., Box 1354, Houston, TX, 77030, USA.
James L MurrayBreast Medical Oncology and Clinical Cancer Genetics, The University of Texas MD Anderson Cancer Center, 1155 Pressler Street, CPB 5., Box 1354, Houston, TX, 77030, USA.
Vicente ValeroBreast Medical Oncology and Clinical Cancer Genetics, The University of Texas MD Anderson Cancer Center, 1155 Pressler Street, CPB 5., Box 1354, Houston, TX, 77030, USA.
Scott M LippmanClinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Powel BrownClinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nour SneigeDepartment of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
The University of Texas MD Anderson Cancer Center · USCancer Genetics (United States) · USNational Cancer Institute · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

Selective estrogen receptor modulators (SERMs), tamoxifen, and raloxifene that reduce the risk of breast cancer are limited to only estrogen receptor-positive (ER(+)) breast cancer. In addition, patient acceptance of SERMs is low due to toxicity and intolerability. New agents with improved toxicity profile that reduce risk of ER-negative breast cancer are urgently needed. Observational studies show that statins can reduce breast cancer incidence and recurrence. The objective of this prospective short-term prevention study was to evaluate the effect of a lipophilic statin, atorvastatin, on biomarkers in breast tissue and serum of women at increased risk. Eligible participants included women with previous history of carcinoma in situ, or atypical hyperplasia, or 5 year breast cancer projected Gail risk >1.67 %, or lifetime breast cancer risk >20 % calculated by models including Claus, Tyrer-Cuzick, Boadicea, or BRCAPRO. Patients underwent baseline fine needle aspiration (FNA) of the breast, blood collection for biomarker analysis, and were randomized to either no treatment or atorvastatin at 10, 20, or 40 mg/day dose for 3 months. At 3 months, blood collection and breast FNA were repeated. Biomarkers included C-reactive protein (CRP), lipid profile, atorvastatin, and its metabolites, Ki-67, bcl-2, EGFR, and pEGFR. Baseline genotype for 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMG-CoAR) was also measured. Among 60 patients evaluated, a significant reduction in serum CRP, cholesterol and low-density lipoprotein (LDL), and increase in atorvastatin metabolites in serum and breast FNAs was demonstrated. No changes were observed in other tissue biomarkers. This study shows that atorvastatin and its metabolites are detectable in breast samples and may lower serum CRP among women without hyperlipidemia.

Indexed as

AdultAgedAtorvastatinBiomarkers, TumorBiopsy, Fine-NeedleBreast NeoplasmsCholesterolC-Reactive ProteinDrug Administration ScheduleFemaleHumansLipoproteins, LDLMiddle AgedProspective StudiesTreatment OutcomeAtorvastatinBiomarkers, TumorCholesterolC-Reactive ProteinLipoproteins, LDLAtorvastatinBreast cancer biomarkersBreast cancer riskStatins

Identifiers

PMID27287781
PMCPMC5989315
OpenAlexW2410915387

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.