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Randomized Placebo-controlled Phase III Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia

Phase 3
18 Years
75 Years
Open (Enrolling)
Intraepithelial Carcinoma

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Trial Information

Randomized Placebo-controlled Phase III Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia

Inclusion Criteria:

- Women of age < 75 years

- Women operated on for lobular (LIN 2 and 3) or ER positive or unknown ductal (DIN
1-3, excluded DIN 1a) intraepithelial neoplasia. Both incident (diagnosis within 12
months) and prevalent cases (diagnosis between previous 12 and 60 months) will be
included, upon stratification.

- Written informed consent

Exclusion Criteria:

- Any type of malignancy, with the exclusion of CIN and non-melanoma skin cancer;

- Active proliferative disorders of the endometrium such as atypical hyperplasia,
history of active endometriosis, unresected polyps;

- Alterations of metabolic, liver, renal and cardiac grade 2 function (NCI criteria
grade 2 or higher);

- Any type of retinal disorders or severe cataract;

- Presence of significant risk factors for venous events, including immobilization
within the last 3 months for longer than 2 weeks following surgery or trauma, deep
venous thrombophlebitis or other significant VTE (pulmonary embolism, stroke, etc.);

- Use of tamoxifen, raloxifene or other SERMs within the last 4 weeks;

- Anticoagulant therapy in progress (heparin or dicoumarol);

- Active infections;

- Severe psychiatric disorders or inability to comply to the protocol procedures.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Incidence of invasive breast cancer

Outcome Description:

The Primary endpoint of the proposed trial is to assess if tamoxifene at a low dose, 5mg/d reduces the incidecnce of invasive breast cancer and ductal carcinoma in situ (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.

Outcome Time Frame:

36 months

Safety Issue:



Italy: Italian Medicines Agency

Study ID:

GAL 01



Start Date:

November 2008

Completion Date:

November 2017

Related Keywords:

  • Intraepithelial Carcinoma
  • Neoplasms
  • Carcinoma
  • Carcinoma in Situ