Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer

Phase 4 Completed 104 enrolled Shanghai Jiao Tong University School of Medicine

RandomizedParallel-groupOpen-labelTreatment

Summary

To compare the safety of toremifene and tamoxifen therapy in premenopausal patients with operable breast cancer by monitoring gynecological abnormality,blood lipid level,hepatic abnormality,estrogen level and perimenopausal symptoms.

Timeline

Start: 2014-12
Primary completion: 2018-08
Completion: 2018-08

Outcome

Missed primary endpoint

paper The incidences of ovarian cysts were 42.6% in the TOR group and 51.1% in the TAM group (p = 0.441). PMID 32677982 ↗

Publications

Hong J, Huang J, Shen L, Zhu S, Gao W, Wu J, Huang O, He J, Zhu L, Chen W, Li Y, Chen X, Shen K. A prospective, randomized study of Toremifene vs. tamoxifen for the treatment of premenopausal breast cancer: safety and genital symptom analysis. BMC Cancer. 2020 Jul 16;20(1):663. doi: 10.1186/s12885-020-07156-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Tamoxifen	Small molecule	10 mg	—
Subject	Toremifene	Small molecule	60 mg	—