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Clinical Trials in Italy / NCT01357772
Active, not recruiting Phase 3

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

NCT01357772 · tracked via the Priya Life Science Italy tracker
Sponsor
Andrea DeCensi
Phase
Phase 3
Started
2008-11-12
Last updated
2023-07-17

Condition(s) studied

Carcinoma, Intraductal, NoninfiltratingRecurrence, Local NeoplasmBreast NeoplasmsAtypical Hyperplasia

Investigational drug(s) / intervention(s)

Tamoxifen →placebo

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Women of age ≥ 18 and \< 75 years 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: 1. Any type of malignancy, with the exclusion of non-melanoma skin cancer 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

Primary outcome measure(s)

  • Number of invasive breast cancer events and DCIS — 20 years
    Number of neoplastic events, i.e., invasive breast cancer or ductal carcinoma in situ of the breast from the start of treatment up to at least 16 years from treatment initiation.

Trial sites (14)

FacilityCityRegionStatus
Ospedali riuniti ASL AL - Ospedale SS. Antonio e Margherita Tortona Alessandria
Istituto Scientifico Romagnolo per lo studio e la cura dei tumori Meldola Forlì-Cesena
Ospedale di Carpi "Bernardino Ramazzini" Carpi Modena
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 Naples 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

More Andrea DeCensi trials in Italy

Low Dose Exemestane vs Low Dose Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer. Recruiting

Other trials for the same condition

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer Active, not recruiting
A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010) Recruiting
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) Active, not recruiting
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer Active, not recruiting
A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01357772 on ClinicalTrials.gov ↗ ← All trials in Italy