Efficacy of Tamoxifen Versus Toremifene in CYP2D6 IM/PM of Premenopausal Patients With ER-positive Early Breast Cancer
NCT ID: NCT03351062
Last Updated: 2017-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
844 participants
INTERVENTIONAL
2017-11-30
2025-12-31
Brief Summary
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Detailed Description
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OBJECTIVES:
1. The main purpose of this study is to compare 5-year disease-free survival rate of adjuvant endocrine therapy with tamoxifen and toremifene in premenopausal women with estrogen receptor-positive early breast cancer who are CYP2D6 intermediate/poor metabolizers.
2. The secondary purpose of this study includes:
1. To compare 5-year overall survival (OS) and safety of adjuvant endocrine therapy with tamoxifen and toremifene in premenopausal patients with estrogen receptor-positive early breast cancer who are CYP2D6 intermediate/poor metabolizers.
2. To compare the changes of plasma concentration of the parent drugs and metabolites of tamoxifen and toremifene in premenopausal patients with estrogen receptor-positive early breast cancer who are CYP2D6 intermediate/poor metabolizers.
3. To assess the pharmacokinetics of tamoxifen and toremifene in premenopausal patients with estrogen receptor-positive early breast cancer who are CYP2D6 intermediate/poor metabolizers.
OUTLINE:
First, CYP2D6 genotype screening shall be conducted in premenopausal patients with estrogen receptor-positive early breast cancer in order to determine the frequency of different alleles. Then, patients who are CYP2D6 intermediate/poor metabolizers (with \*4, \*5, \*10, \*14, \*17, \*41 alleles) shall be stratified and randomized at the ratio of 1:1 ratio: allele status of CYP2D6 CYP2D6 intermediate/poor metabolizer (Heterozygous or homozygous), lymph node metastasis (with vs. without), prior chemotherapy (with vs. without), and HER2 status (positive vs. negative). Included patients shall be divided into two groups. One group will be given Tamoxifen (10mg Bid) for 5 years and the other group will be given toremifene (60mg qd) for 5 years. Then 5-year disease-free rate and overall survival and safety will be compared between these two groups. At Month 6, pharmacokinetic study on tamoxifen, toremifene and their metabolites will be conducted on patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tamoxifen treatment group
Patients in this group will receive tamoxifen treatment.
Tamoxifen
Patients will be given 10mg Tamoxifen twice a day.
Toremifene treatment group
Patients in this group will receive Toremifene treatment.
Toremifene
Patients will be given 60mg Toremifene once a day.
Interventions
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Tamoxifen
Patients will be given 10mg Tamoxifen twice a day.
Toremifene
Patients will be given 60mg Toremifene once a day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
50 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Henan Cancer Hospital
OTHER_GOV
The First Hospital of Jilin University
OTHER
Southwest Hospital, China
OTHER
First Hospital of China Medical University
OTHER
Guangdong Provincial People's Hospital
OTHER
Harbin Medical University
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Jiangsu Provincial People's Hospital
OTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Zhejiang Cancer Hospital
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
Union hospital of Fujian Medical University
OTHER
Hebei Tumor Hospital
OTHER
Hunan Cancer Hospital
OTHER
Affiliated Hospital of Qinghai University
OTHER
Wuhan TongJi Hospital
OTHER
Hainan People's Hospital
OTHER
The Third Affiliated Hospital of Kunming Medical College.
OTHER
The Third Affiliated Hospital of Nanchang University
OTHER
Chinese Anti-Cancer Association
OTHER
Responsible Party
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Principal Investigators
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Zhimin Shao, Master
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Southwest Hospital, China
Chongqing, Chongqing Municipality, China
Union hospital of Fujian Medical University
Fuzhou, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Hainan People's Hospital
Haikou, Hainan, China
Hebei Tumor Hospital
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Wuhan Tongji Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
The Third Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
First Hospital of Jilin University
Changchun, Jilin, China
First Hospital of China Medical University
Shenyang, Lining, China
First Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The Third Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Xiang Wang, M. D.
Role: primary
Guosheng Ren, M. D.
Role: primary
Jun Jiang, M. D.
Role: primary
Chuangui Song, M. D.
Role: primary
Ning Liao, M. D.
Role: primary
Erwei Song, M. D.
Role: primary
Xiaojie Zhong, M. D.
Role: primary
Cuizhi Geng, M. D.
Role: primary
Da Pang, M. D.
Role: primary
Shude Cui, M. D.
Role: primary
Xingrui Li, M. D.
Role: primary
Lizhi Ouyang, M. D.
Role: primary
Shui Wang, M. D.
Role: primary
Yali Cao, M. D.
Role: primary
Zhimin Fan, M. D.
Role: primary
Feng Jin, M. D.
Role: primary
Haibo Wang, M. D.
Role: primary
Zhimin Shao, M. D.
Role: primary
Ayong Cao, M. D.
Role: backup
Jin Zhang, M. D.
Role: primary
Dedian Chen, M. D.
Role: primary
Hongjian Yang, M. D.
Role: primary
Other Identifiers
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CYP2D6-1.1
Identifier Type: -
Identifier Source: org_study_id