Low-Dose Tamoxifen for Radiation-Induced Breast Cancer Risk Reduction: A Phase IIB Randomized Placebo-Controlled Trial (LDTam)

NCT01196936 Phase 2 ACTIVE_NOT_RECRUITING Results posted

Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast cancer risk in radiation-induced cancer survivors.

Details

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	84
Start date	2010-09
Completion	2028-12-11

Conditions

• Breast Cancer

Interventions

• Tamoxifen Citrate
• Placebo
• Digital mammography
• immunohistochemistry staining method
• pharmacological study
• laboratory biomarker analysis
• protein expression analysis
• pharmacogenomic studies
• questionnaire administration
• Fine needle aspiration

Primary outcomes

• Mammographic Breast Density — At year two post treatment
  Mammographic density was quantified as percentage of fibroglandular tissue. Using an intention-to-treat analysis, mammographic breast density (MBD) was compared between patients in the low dose tamoxifen intervention and placebo group by applying the linear mixed effects model for normally distributed data.

Countries

United States, Canada