drugset / Trial / NCT06671912

Testing Low Dose Tamoxifen for Invasive Breast Cancer, LoTam Trial

NCT06671912

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase III trial compares the effect of low dose tamoxifen to usual hormonal therapy, including aromatase inhibitors, in treating post-menopausal women with hormone positive, HER2 negative early stage breast cancer. Tamoxifen is in a class of medications known as antiestrogens. It blocks the activity of estrogen (a female hormone) in the breast. This may stop the growth of some breast tumors that need estrogen to grow. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, prevent the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. Aromatase inhibitors are used as a type of hormone therapy to treat postmenopausal women with hormone-dependent breast cancer. Giving low dose tamoxifen may be more effective compared to usual hormone therapy in treating post-menopausal women with hormone-positive, HER2 negative early stage breast cancer.

Timeline

Start
2025-02-19
Primary completion
2030-11-30
Completion
2031-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tamoxifen Small molecule Oral
Comparator Anastrozole Other / unclassified Oral
Comparator Exemestane Small molecule Oral
Comparator Letrozole Other / unclassified Oral