drugset / Trial / NCT03351062
Efficacy of Tamoxifen Versus Toremifene in CYP2D6 IM/PM of Premenopausal Patients With ER-positive Early Breast Cancer
Phase 3
Unknown
844 enrolled
Chinese Anti-Cancer Association
Affiliated Hospital of Qinghai University · collabCancer Institute and Hospital, Chinese Academy of Medical Sciences · collabFirst Affiliated Hospital of Chongqing Medical University · collabFirst Hospital of China Medical University · collabFudan University · collabGuangdong Provincial People's Hospital · collabHainan People's Hospital · collabHarbin Medical University · collabHebei Tumor Hospital · collabHenan Cancer Hospital · collabHunan Cancer Hospital · collabJiangsu Provincial People's Hospital · collabSouthwest Hospital, China · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collabThe First Hospital of Jilin University · collabThe Third Affiliated Hospital of Kunming Medical College. · collabThe Third Affiliated Hospital of Nanchang University · collabTianjin Medical University Cancer Institute and Hospital · collabUnion hospital of Fujian Medical University · collabWuhan TongJi Hospital · collabZhejiang Cancer Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This clinical trial is designed to be a multi-center prospective, parallel-controlled Phase III clinical study. In this study, the efficacy of tamoxifen versus toremifene shall be compared in CYP2D6 intermediate/poor metabolizers of premenopausal patients with estrogen receptor-positive early breast cancer.
Timeline
- Start
- 2017-11
- Primary completion
- 2025-12
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tamoxifen | Small molecule | 10 mg | — |
| Comparator | Toremifene | Small molecule | 60 mg | — |