Evidence map›Paper›PMID 32996592›Full record

Trial reportClinical pharmacology and therapeutics2021

Local Transdermal Delivery of Telapristone Acetate Through Breast Skin, Compared With Oral Treatment: A Randomized Double-Blind, Placebo-Controlled Phase II Trial.

Oukseub Lee, Melissa Pilewskie, Scott Karlan, Mary B Tull, Kelly Benante, Yanfei Xu, Luis Blanco, Irene Helenowski, Masha Kocherginsky, Shivangi Yadav and 9 more

Open access · greenAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.7field-weighted citation impact, top 10% 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

8 citing papers in PubMed, 22 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Current status and challenges of breast cancer prevention~DNA methylation would lead to groundbreaking progress in breast cancer prevention~.Genes and environment : the official journal of the Japanese Environmental Mutagen Society · 2023
    Review
  5. Article
  6. Review
  7. Article
  8. Article
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

19 authors at 6 institutions in 1 country.

Oukseub LeeDepartment of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Melissa PilewskieDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Scott KarlanDepartment of Surgery, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Mary B TullDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Kelly BenanteDepartment of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Yanfei XuDepartment of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Luis BlancoDepartment of Pathology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Irene HelenowskiDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Masha KocherginskyDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Shivangi YadavDepartment of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Omid HosseiniDepartment of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Nora HansenDepartment of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Kevin BethkeDepartment of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Miguel MuzzioAnalytical Chemistry Division, Illinois Institute of Technology Research Institute, Chicago, Illinois, USA.
Melissa A TroesterDepartment of Epidemiology, University of North Carolina, Chapel Hill, North Carolina, USA.
Eileen DimondNational Cancer Institute Division of Cancer Prevention, Bethesda, Maryland, USA.
Marjorie PerloffNational Cancer Institute Division of Cancer Prevention, Bethesda, Maryland, USA.
Brandy Heckman-StoddardNational Cancer Institute Division of Cancer Prevention, Bethesda, Maryland, USA.
Seema A KhanDepartment of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Northwestern University · USNational Cancer Institute · USCedars-Sinai Medical Center · USIllinois Institute of Technology · USMemorial Sloan Kettering Cancer Center · USUniversity of North Carolina at Chapel Hill · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
UNC-CH CENTER FOR ENVIRONMENTAL HEALTH &SUSCEPTIBILITYP30ES010126 · NIEHS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Stephanie Engel · 2001 to 2026
$36.3M
NCI NIH HHS HHSN261201000035INCI NIH HHS HHSN261201200035INCI NIH HHS P30 CA008748NIEHS NIH HHS P30 ES010126
6 · The paper itself

Abstract

Oral breast cancer prevention medications entail systemic exposure, limiting acceptance by high-risk women. Delivery through the breast skin, although an attractive alternative, requires demonstration of drug distribution throughout the breast. We conducted a randomized double-blind, placebo-controlled phase II clinical trial comparing telapristone acetate, a progesterone receptor antagonist, administered orally (12 mg/day) or transdermally (12 mg/breast) for 4 ± 1 weeks to women planning mastectomy. Plasma and tissue concentrations, measured at five locations in the mastectomy specimen using liquid chromatography tandem mass spectrometry were compared. In 60 evaluable subjects, median drug concentration (ng/g tissue) was 103 (interquartile range (IQR): 46.3-336) in the oral vs. 2.82 (IQR: 1.4-5.5) in the transdermal group. Despite poor dermal permeation, within-breast drug distribution pattern was identical in both groups (R

Indexed as

Neoadjuvant TherapySkin AbsorptionAdiposityAdministration, CutaneousAdministration, OralAdultAntineoplastic AgentsBreast NeoplasmsChemotherapy, AdjuvantChromatography, LiquidDouble-Blind MethodDrug MonitoringFemaleHumansMastectomyMiddle AgedAntineoplastic AgentsNorpregnadienestelapristone acetate

Identifiers

PMID32996592
PMCPMC8388824
OpenAlexW3090399818

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.