Overview

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

Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chinese Anti-Cancer Association
Collaborators:
Affiliated Hospital of Qinghai University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First Affiliated Hospital of Chongqing Medical University
First Hospital of China Medical University
First Hospital of Jilin University
Fudan University
Guangdong Provincial People's Hospital
Hainan People's Hospital
Harbin Medical University
Hebei Tumor Hospital
Henan Cancer Hospital
Hunan Cancer Hospital
Jiangsu Provincial People's Hospital
Southwest Hospital, China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The First Hospital of Jilin University
The Third Affiliated Hospital of Kunming Medical College.
The Third Affiliated Hospital of Nanchang University
Tianjin Medical University Cancer Institute and Hospital
Union hospital of Fujian Medical University
Wuhan TongJi Hospital
Zhejiang Cancer Hospital
Treatments:
Tamoxifen
Toremifene
Criteria
Inclusion Criteria:

1. Premenopausal women aged 18-50 years;

2. ECOG PS: 0-2 points;

3. Invasive breast cancer confirmed by histology with ER ≥ 10% (all test results should
be reviewed and confirmed by Department of Pathology of the participant institution);

4. Participants have completed the standard local radical treatment (modified or
conservative radical mastectomy) with or without neo-adjuvant/adjuvant chemotherapy or
radiotherapy;

5. Participants must be able to understand this study and are willing to participate,
agree to genotype screening and sign informed consent form with good compliance and
cooperation in follow-ups;

6. Polymorphism analysis showed that patients are CYP2D6 * 4, * 5, * 10, * 14, * 17, * 41
allele carriers;

7. Hemoglobin ≥ 90g/L, neutrophils ≥ 1.5 × 109/L, platelets ≥ 75 × 109/L, AST and ALT ≤
2.5 times the upper limit of normal (ULN), serum creatinine and urea nitrogen ≤ ULN.

Exclusion Criteria:

1. Patients have previously received neoadjuvant endocrine therapy or have started
adjuvant endocrine therapy;

2. There are any comorbidities that may increase the level of sex hormones: such as
pituitary adenomas, ovarian tumors, thymic carcinomas, etc.;

3. There are any comorbidities that may reduce the level of sex hormones such as
hyperthyroidism, hypothyroidism, cirrhosis, severe malnutrition, Turner syndrome, lack
of sex hormone synthetase, intracranial tumors, pituitary atrophy etc.;

4. Patients have undergone or planned to conduct ovariectomy or ovarian function
inhibition;

5. Patients needs to take other medicines which can influence the activity of CYP2D6
(such as fluoxetine, paroxetine, quinidine, bupropion), CYP3A4 (such as erythromycin,
acetylspiramycin, ritonavir, ketoconazole, nicardipine);

6. Patients have been treated with other trial medications in the past 2 weeks;

7. Pregnant or lactating women (women of childbearing age must have a negative pregnancy
test within 14 days of the first dosing, and if pregnant, Patients are required for
ultrasound examination to exclude pregnancy);

8. Women of childbearing age who are not willing to take effective contraception during
treatment;

9. There are serious non-malignant tumor comorbidities that may affect long-term
follow-up;

10. Patients have family history of endometrial, ovarian or other gynecologic
malignancies;

11. Transvaginal ultrasound suggested more serious ovarian abnormalities or endometrial
thickening;

12. Patients have had thrombotic events such as cerebrovascular accident (including
transient ischemic attack), deep venous thrombosis, and pulmonary embolism within 6
months prior to study initiation;

13. Serious liver insufficiency with Child-Pugh C grade;

14. Serious cardiac insufficiency with New York Heart Association (NYHA) grade ≥III;

15. Patients are known severely allergic to study drug;

16. Patients have history of other malignancies in the past five years, except for
cutaneous basal cell carcinoma and cervical carcinoma in situ which have been cured;

17. In other cases, the researchers don't think the subjects are suitable for participate
in the study.