Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia - Long Term Follow-up
NCT ID: NCT01357772
Last Updated: 2023-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2008-11-12
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To improve the risk-benefit ratio, the use of lower doses of the drug has been proposed.
Biomarker trials revealed that 5 mg/d was noninferior to 20 mg/d in inhibiting proliferation of breast cancer and normal endometrial tissue.
By contrast, the risk of endometrial cancer si dose-dependent, and the dose reduction can lead a substantial decrease. Morover a dose of 5 mg/day is associated with an overall decrease of the estrogenic activity of tamoxifen on insulin like growth factor (IGF-I), sex hormone-binding globulin (SHBG) and antithrombin-III, with a decrease of venous thromboembolic events. Moreover, tamoxifen exhibits a high tissue distribution, so that a dose of 5 mg/day attains at the breast tissue level a concentration 10 times higher than that needed to inhibit cell growth in vitro.
A prospective cohort study also showed that 10 mg on alternate days halves recurrence of DCIS in postmenopausal women.
It has been shown that the treatment of dysplasia or pre-cancer drives the reduction of the invasive neoplasms onset. This is a chemoprevention trial designed to validatate the low-dose Tamoxifen in women with diseases at high evolutionary risk. The demonstration of efficacy and safety of such a treatment for the prevention of the invasive breast cancer would lead improvements in term of survival and quality of life for the patients at increased risk.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long-term Follow-up of the TAM-01 Study
NCT06982313
Phase III, Randomized, Double Blind Trial Low Dose Tamoxifen Versus Placebo in Hormone Replacement Therapy (HRT) Users
NCT01579734
Tamoxifen in Treating Women With High-Risk Breast Cancer
NCT00002542
Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer
NCT05941520
Therapeutic Dose Monitoring (TDM) of Tamoxifen
NCT05133674
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tamoxifen
tamoxifen at daily dose of 5 mg for a total treatment time of 3 years
Tamoxifen
placebo
placebo at daily dose of 5 mg for a total treatment time of 3 years
placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tamoxifen
placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Women operated on for lobular (LIN 2 and 3) or ER positive or unknown ductal DCIS, i.e DIN 1-3, but DIN 1a excluded) intraepithelial neoplasia in the 5 years (60 months) prior the inclusion in the study. Both incident (diagnosis \< 12 months) and prevalent cases diagnosis ≥12, and \< 60 months) will be included, including recurrent cases
3. ECOG Performance status ≤ 1
4. Written informed consent
Exclusion Criteria
2. Proliferative disorders of the endometrium such as atypical hyperplasia, endometriosis, unresected polyps, symptomatic myoma
3. Liver, kidney and heart function impairment grade ≥ 2 (CTCAE criteria v.3.0)
4. Any type of retinal disorders, severe cataract and glaucoma
5. Presence of significant risk factors for venous events, including immobilization after trauma within the last 3 months for longer than 2 weeks, deep venous thrombophlebitis or other significant venous thrombotic event,VTE (pulmonary embolism, stroke, etc.)
6. Use of tamoxifen, raloxifene or other selective estrogen receptor modulator (SERMs)
7. Use of anastrozole and other aromatase inhibitors (AI) in the last 12 months for ≥ 6 months
8. Dicoumarol anticoagulant therapy in progress
9. Active infections
10. Severe psychiatric disorders or inability to comply to the protocol procedures
11. Geographic inaccessibility or difficulties in ensuring adequate compliance
12. Women who are pregnant or breastfeeding
13. Any other factor which, at the discretion of the investigator, may controindicate the use of tamoxifen
18 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Associazione Italiana per la Ricerca sul Cancro
OTHER
European Institute of Oncology
OTHER
Andrea DeCensi
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Andrea DeCensi
Medical Oncology Director
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrea DeCensi, MD
Role: PRINCIPAL_INVESTIGATOR
E.O.Ospedali Galliera
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ospedali riuniti ASL AL - Ospedale SS. Antonio e Margherita
Tortona, Alessandria, Italy
Istituto Scientifico Romagnolo per lo studio e la cura dei tumori
Meldola, Forlì-Cesena, Italy
Ospedale di Carpi "Bernardino Ramazzini"
Carpi, Modena, Italy
IRCCS Istituto Tumori Giovanni Paolo II
Bari, , Italy
Azienda Ospedaliera Mater Domini Catanzaro
Catanzaro, , Italy
E.O. Ospedali Galliera
Genoa, , Italy
IEO - European Institute of Oncology IRCCS
Milan, , Italy
Azienda Ospedaliera-Universitaria Policlinico di Modena
Modena, , Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli, , Italy
ICS Maugeri -Centro Medico di Pavia
Pavia, , Italy
AUSL - Oncologia Medica
Ravenna, , Italy
Azienda Ospedaliera-Universitaria Città della Salute e della Scienza di Torino
Torino, , Italy
Azienda Socio-Sanitaria Territoriale Sette Laghi, Varese
Varese, , Italy
Azienda ULSS8 Berica
Vicenza, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
DeCensi A, Puntoni M, Johansson H, Guerrieri-Gonzaga A, Caviglia S, Avino F, Cortesi L, Ponti A, Pacquola MG, Falcini F, Gulisano M, Digennaro M, Cariello A, Cagossi K, Pinotti G, Lazzeroni M, Serrano D, Briata IM, Buttiron Webber T, Boni L, Bonanni B. Effect Modifiers of Low-Dose Tamoxifen in a Randomized Trial in Breast Noninvasive Disease. Clin Cancer Res. 2021 Jul 1;27(13):3576-3583. doi: 10.1158/1078-0432.CCR-20-4213. Epub 2021 Feb 19.
Lazzeroni M, Serrano D, Dunn BK, Heckman-Stoddard BM, Lee O, Khan S, Decensi A. Oral low dose and topical tamoxifen for breast cancer prevention: modern approaches for an old drug. Breast Cancer Res. 2012 Oct 29;14(5):214. doi: 10.1186/bcr3233.
DeCensi A, Johansson H, Helland T, Puntoni M, Macis D, Aristarco V, Caviglia S, Webber TB, Briata IM, D'Amico M, Serrano D, Guerrieri-Gonzaga A, Bifulco E, Hustad S, Soiland H, Boni L, Bonanni B, Mellgren G. Association of CYP2D6 genotype and tamoxifen metabolites with breast cancer recurrence in a low-dose trial. NPJ Breast Cancer. 2021 Mar 25;7(1):34. doi: 10.1038/s41523-021-00236-6.
Lazzeroni M, Puntoni M, Guerrieri-Gonzaga A, Serrano D, Boni L, Buttiron Webber T, Fava M, Briata IM, Giordano L, Digennaro M, Cortesi L, Falcini F, Serra P, Avino F, Millo F, Cagossi K, Gallerani E, De Simone A, Cariello A, Aprile G, Renne M, Bonanni B, DeCensi A. Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Recurrence in Breast Noninvasive Neoplasia: A 10-Year Follow-Up of TAM-01 Study. J Clin Oncol. 2023 Jun 10;41(17):3116-3121. doi: 10.1200/JCO.22.02900. Epub 2023 Mar 14.
Carbone A, Oliva M, Puntoni M, Guerrieri-Gonzaga A, Briata IM, Lazzeroni M, Serrano D, Giordano L, Digennaro M, Cortesi L, Millo F, Cagossi K, Aprile G, Serra P, Gallerani E, Bonanni B, DeCensi A. Effect of low-dose tamoxifen on benign gynecological and breast conditions in a phase III trial in non-invasive breast cancer. J Natl Cancer Inst. 2025 Aug 28:djaf250. doi: 10.1093/jnci/djaf250. Online ahead of print.
DeCensi A, Puntoni M, Guerrieri-Gonzaga A, Caviglia S, Avino F, Cortesi L, Taverniti C, Pacquola MG, Falcini F, Gulisano M, Digennaro M, Cariello A, Cagossi K, Pinotti G, Lazzeroni M, Serrano D, Branchi D, Campora S, Petrera M, Buttiron Webber T, Boni L, Bonanni B. Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Local and Contralateral Recurrence in Breast Intraepithelial Neoplasia. J Clin Oncol. 2019 Jul 1;37(19):1629-1637. doi: 10.1200/JCO.18.01779. Epub 2019 Apr 11.
Related Links
Access external resources that provide additional context or updates about the study.
PubMed ID: 33608319
PubMed ID: 23106852
PubMed ID: 33767162
PMID: 36917758
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2007-007740-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GAL 01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.