Ignite Creation Date:
2024-05-05 @ 11:32 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01357772
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-17
First Post:
2011-05-17
Brief Title:
Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia - Long Term Follow-up
Sponsor:
Andrea DeCensi
Organization:
Ente Ospedaliero Ospedali Galliera
Study Overview
Official Title:
Randomized Placebo-controlled Phase III Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia - Long Term Follow-up
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAM-01
Brief Summary:
The aim of the study is to evaluate whether tamoxifen at a low dose of 5mgd 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 mgd was noninferior to 20 mgd 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 mgday 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 mgday 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
To improve the risk-benefit ratio the use of lower doses of the drug has been proposed
Biomarker trials revealed that 5 mgd was noninferior to 20 mgd 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 mgday 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 mgday 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
Detailed Description:
Italian multicenter phase III trial controlled parallel group comparision randomized 11 duble blind tamoxifen 5 mgd versus placebo administered for 3 years A total of 500 women 75 years of age or younger with newly diagnosed non-invasive breast cancer have been included in the study The long-term study implies a minimum 10 year follow up after treatment completion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-007740-10 | EUDRACT_NUMBER | None | None |