Evidence map›Paper›PMID 30973790›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Local and Contralateral Recurrence in Breast Intraepithelial Neoplasia.

Andrea DeCensi, Matteo Puntoni, Aliana Guerrieri-Gonzaga, Silvia Caviglia, Franca Avino, Laura Cortesi, Cristiana Taverniti, Maria Grazia Pacquola, Fabio Falcini, Marcella Gulisano and 12 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04933240 (Tamoxifen Versus Estradiol in the Prevention of Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Controlled Pilot Trial), which is not on this map. Cited by 90 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 1 pooled it
7.9field-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.

NCT04933240 phase4withdrawnnot on this mapstarted 2022, after this paper: background citation

Tamoxifen Versus Estradiol in the Prevention of Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Controlled Pilot Trial

TypeinterventionalSponsorVirginia Commonwealth UniversityRan2022 to 2024Enrolled0ConditionsVaginal BleedingArmsTamoxifen Citrate 10Mg Tab, Estradiol, Placebo
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 1 synthesis or guideline pooled it, 209 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Preventative therapy for breast cancer: a clinical experience.Breast cancer research and treatment · 2023
    Trial
  5. Trial
  6. Trial
  7. Trial
  8. Low-Dose Tamoxifen for Mammographic Density Reduction: A Randomized Controlled Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
    Trial
  9. A Randomized Phase IIb Study of Low-dose Tamoxifen in Chest-irradiated Cancer Survivors at Risk for Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Trial
  10. Trial
  11. Trial
  12. Review
  13. Review
  14. Observational
  15. Article
  16. Article
  17. Article
  18. Signaling pathways and targeted interventions for precancers.Signal transduction and targeted therapy · 2026
    Review
  19. Article
  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 12 institutions in 2 countries.

Andrea DeCensi1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.
Matteo Puntoni1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.
Aliana Guerrieri-Gonzaga3 European Institute of Oncology IRCCS, Milan, Italy.
Silvia Caviglia1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.
Franca Avino4 Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy.
Laura Cortesi5 Azienda Ospedaliera-Universitaria Policlinico di Modena, Modena, Italy.
Cristiana Taverniti6 Azienda Ospedaliera-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.
Maria Grazia Pacquola7 Ospedale SS Antonio e Margherita-ASL AL, Tortona, Italy.
Fabio Falcini8 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.
Marcella Gulisano9 ULSS 6 Vicenza, Vicenza, Italy.
Maria Digennaro10 IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy.
Anna Cariello11 Azienda Unità Sanitaria Locale della Romagna, Ravenna, Italy.
Katia Cagossi12 Ospedale Bernardino Ramazzini, Carpi, Italy.
Graziella Pinotti13 Azienda Socio-Sanitaria Territoriale Sette Laghi, Varese, Italy.
Matteo Lazzeroni3 European Institute of Oncology IRCCS, Milan, Italy.
Davide Serrano3 European Institute of Oncology IRCCS, Milan, Italy.
Daniela Branchi1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.
Sara Campora1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.
Marilena Petrera1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.
Tania Buttiron Webber1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.
Luca Boni14 Azienda Ospedaliera-Universitaria Careggi, Florence, Italy.
Bernardo Bonanni3 European Institute of Oncology IRCCS, Milan, Italy.
Ente Ospedaliero Ospedali Galliera · ITEuropean Institute of Oncology · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITAzienda Ospedaliero-Universitaria Careggi · ITAzienda Socio Sanitaria Territoriale Lariana · ITAzienda Unità Sanitaria Locale Della Romagna · ITIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITIstituto Ramazzini · ITOspedale Sant Antonio · ITPoliclinico di Modena · ITQueen Mary University of London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTamoxifen administered for 5 years at 20 mg/d is effective in breast cancer treatment and prevention, but toxicity has limited its broad use. Biomarker trials showed that 5 mg/d is not inferior to 20 mg/d in decreasing breast cancer proliferation. We hypothesized that a lower dose given for a shorter period could be as effective in preventing recurrence from breast intraepithelial neoplasia but have a lower toxicity than the standard dose. PATIENTS AND

methodsWe conducted a multicenter randomized trial of tamoxifen, 5 mg/d or placebo administered for 3 years after surgery in women with hormone-sensitive or unknown breast intraepithelial neoplasia, including atypical ductal hyperplasia and lobular or ductal carcinoma in situ. The primary end point was the incidence of invasive breast cancer or ductal carcinoma in situ.

resultsFive hundred women 75 years of age or younger were included. After a median follow-up of 5.1 years (interquartile range, 3.9-6.3 years), there were 14 neoplastic events with tamoxifen and 28 with placebo (11.6

conclusionTamoxifen at 5 mg/d for 3 years can halve the recurrence of breast intraepithelial neoplasia with a limited toxicity, which provides a new treatment option in these disorders.

Indexed as

Neoplasm Recurrence, LocalAgedAntineoplastic Agents, HormonalBiomarkers, TumorBreast NeoplasmsCarcinoma, Intraductal, NoninfiltratingDrug Administration ScheduleFemaleFollow-Up StudiesHumansIncidenceMiddle AgedPlacebosResearch DesignTamoxifenTreatment OutcomeAntineoplastic Agents, HormonalBiomarkers, TumorPlacebosTamoxifen

Identifiers

PMID30973790
PMCPMC6601429
OpenAlexW2938233323

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.