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

Plain-language summary

This study compares low-dose Tamoxifen with placebo in women with breast intraepithelial neoplasia (pre-cancerous breast changes; LIN, DCIS/DIN) and follows them long-term. It included women aged 18-75 operated on for these changes within the past 5 years. It was a Phase 3 study, ongoing but not currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Active, not recruiting

Sponsor

Andrea DeCensi

Intervention

Tamoxifen, placebo

Start date

11/12/2008

Estimated completion

12/31/2028

Countries

Italy

Related genes

Locations

• Tortona, Italy
• Meldola, Italy
• Carpi, Italy
• Bari, Italy
• Catanzaro, Italy
• Genoa, Italy
• Milan, Italy
• Modena, Italy
• Naples, Italy
• Pavia, Italy
• Ravenna, Italy
• Torino, Italy
• Varese, Italy
• Vicenza, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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