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Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia - Long Term Follow-up

Study acronym: TAM-01
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date changed from estimate of Dec 31, 2028 to Dec 31, 2022
    • Publications: details revised at 1 of 5 entries
    v10
  2. Re-verified, no change to tracked fieldsv9
  3. Study sites: 11 to 14
    • Secondary endpoints: details revised at 1 of 3 entries
    v8
  4. Primary completion date: Dec 2019 to Dec 31, 2028v7 Show 10 more changesShow less
    • Primary endpoint revised
    • Enrollment target: estimated 1400 to confirmed 500
    • Study sites: 15 to 11
    • Study completion date: Dec 2023 to Dec 31, 2028
    • Start date: Nov 2008 to Nov 12, 2008
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints: 2 to 3
    • Study description expanded, about 37 words
    • Publications: 4 to 5
    • Study title expanded, about 4 words
  5. Site details revised at 13 of 15 sitesv6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 18 to 15
    • Study completion date: Dec 2019 to Dec 2023
    v5
  2. Primary completion date: Nov 2015 to Dec 2019
    • Study sites: 1 to 18
    • Study completion date: Nov 2017 to Dec 2019
    v4
  3. Study description expanded, about 21 wordsv3
  4. Lead sponsor: Ente Ospedaliero Ospedali Galliera to Andrea DeCensi
    • Secondary endpoints: details revised at 1 of 2 entries
    • Eligibility criteria expanded, about 5 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aim of the study is to evaluate whether tamoxifen at a low dose of 5mg/d reduces in the long term the incidence of invasive breast cancer and ductal carcinoma in situ, DCIS (DIN 1c, 2, 3) of the breast, in woman operated for lobular intraepithelial neoplasia (LIN1, 2 and 3) or ER-positive ductal intraepithelial neoplasia (DIN 1b, DIN2, DIN3, 1a excluded) of the breast. 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.
Trial Details
NCT Number NCT01357772
Lead Sponsor Andrea DeCensi
Collaborators: Associazione Italiana per la Ricerca sul Cancro, European Institute of Oncology
Conditions
(from sponsor)		 Carcinoma, Intraductal, Noninfiltrating, Recurrence, Local Neoplasm, Breast Neoplasms, Atypical Hyperplasia
Related terms Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Neoplasm Recurrence, Local
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov