A Randomized Phase IIb Study of Low-dose Tamoxifen in Chest-irradiated Cancer Survivors at Risk for Breast Cancer.
Adult
Biomarkers, Tumor
/ analysis
Breast
/ diagnostic imaging
Breast Density
/ drug effects
Breast Neoplasms
/ diagnosis
Cancer Survivors
/ statistics & numerical data
Dose-Response Relationship, Drug
Female
Humans
Mammography
/ statistics & numerical data
Middle Aged
Neoplasms, Radiation-Induced
/ diagnosis
Organs at Risk
/ diagnostic imaging
Tamoxifen
/ administration & dosage
Treatment Outcome
Journal
Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN: 1557-3265
Titre abrégé: Clin Cancer Res
Pays: United States
ID NLM: 9502500
Informations de publication
Date de publication:
15 02 2021
15 02 2021
Historique:
received:
14
09
2020
revised:
11
11
2020
accepted:
30
11
2020
pubmed:
5
12
2020
medline:
21
1
2022
entrez:
4
12
2020
Statut:
ppublish
Résumé
Low-dose tamoxifen reduces breast cancer risk, but remains untested in chest-irradiated cancer survivors-a population with breast cancer risk comparable with We conducted an investigator-initiated, randomized, phase IIb, double-blinded, placebo-controlled trial (FDA IND107367) between 2010 and 2016 at 15 U.S. sites. Eligibility included ≥12 Gy of chest radiation by age 40 years and age at enrollment ≥25 years. Patients were randomized 1:1 to low-dose tamoxifen (5 mg/day) or identical placebo tablets for 2 years. The primary endpoint was mammographic dense area at baseline, 1 and 2 years. IGF-1 plays a role in breast carcinogenesis; circulating IGF-1 and IGF-BP3 levels at baseline, 1 and 2 years served as secondary endpoints. Seventy-two participants (low-dose tamoxifen: In this randomized trial in chest-irradiated cancer survivors, we find that low-dose tamoxifen is effective in reducing established biomarkers of breast cancer risk and could serve as a risk-reduction strategy.
Identifiants
pubmed: 33272980
pii: 1078-0432.CCR-20-3609
doi: 10.1158/1078-0432.CCR-20-3609
pmc: PMC7887034
mid: NIHMS1652686
doi:
Substances chimiques
Biomarkers, Tumor
0
Tamoxifen
094ZI81Y45
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
967-974Subventions
Organisme : NCI NIH HHS
ID : P30 CA046592
Pays : United States
Organisme : NCI NIH HHS
ID : R01 CA140245
Pays : United States
Informations de copyright
©2020 American Association for Cancer Research.
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