Efficacy of Tamoxifen Versus Toremifene in CYP2D6 IM/PM of Premenopausal Patients With ER-positive Early Breast Cancer

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.

Conditions

• Breast Cancer Female

Interventions

DRUG

Tamoxifen

Patients will be given 10mg Tamoxifen twice a day.

DRUG

Toremifene

Patients will be given 60mg Toremifene once a day.

Sponsors & Collaborators

• Fudan University

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• The First Hospital of Jilin University

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Harbin Medical University

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Jiangsu Provincial People's Hospital

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Union hospital of Fujian Medical University

  collaborator OTHER

• Hebei Tumor Hospital

  collaborator OTHER

• Hunan Cancer Hospital

  collaborator OTHER

• Affiliated Hospital of Qinghai University

  collaborator OTHER

• Wuhan TongJi Hospital

  collaborator OTHER

• Hainan People's Hospital

  collaborator OTHER

• The Third Affiliated Hospital of Kunming Medical College.

  collaborator OTHER

• The Third Affiliated Hospital of Nanchang University

  collaborator OTHER

• Chinese Anti-Cancer Association

  lead OTHER

Principal Investigators

• Zhimin Shao, Master · Fudan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-30

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• China

Study Locations