NCT03351062

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
844

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2017

Longer than P75 for phase_3

Geographic Reach
1 country

21 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 22, 2017

Status Verified

November 1, 2017

Enrollment Period

8.1 years

First QC Date

November 20, 2017

Last Update Submit

November 20, 2017

Conditions

Breast Cancer Female

Keywords

premenopausalearly breast cancerestrogen receptor positive

Outcome Measures

Primary Outcomes (1)

  • Disease-Free Survival

    The time period from randomization to local or distant invasive cancer recurrence, contralateral invasive breast cancer, second (non-breast) primary invasive cancer and all-cause death

    Within 5 years after randomization

Secondary Outcomes (3)

  • Overall Survival

    Within 5 years after randomization

  • Adverse drug reaction

    Within 5 years after administration

  • Serum drug concentration

    Within 6 months after administration

Study Arms (2)

Tamoxifen treatment group

ACTIVE COMPARATOR

Patients in this group will receive tamoxifen treatment.

Drug: Tamoxifen

Toremifene treatment group

ACTIVE COMPARATOR

Patients in this group will receive Toremifene treatment.

Drug: Toremifene

Interventions

TamoxifenDRUG

Patients will be given 10mg Tamoxifen twice a day.

Also known as: Tamoxifen citrate
Tamoxifen treatment group
ToremifeneDRUG

Patients will be given 60mg Toremifene once a day.

Also known as: fareston
Toremifene treatment group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal women aged 18-50 years;
  • ECOG PS: 0-2 points;
  • 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);
  • Participants have completed the standard local radical treatment (modified or conservative radical mastectomy) with or without neo-adjuvant/adjuvant chemotherapy or radiotherapy;
  • 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;
  • Polymorphism analysis showed that patients are CYP2D6 \* 4, \* 5, \* 10, \* 14, \* 17, \* 41 allele carriers;
  • 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.

You may not qualify if:

  • Patients have previously received neoadjuvant endocrine therapy or have started adjuvant endocrine therapy;
  • There are any comorbidities that may increase the level of sex hormones: such as pituitary adenomas, ovarian tumors, thymic carcinomas, etc.;
  • 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.;
  • Patients have undergone or planned to conduct ovariectomy or ovarian function inhibition;
  • 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);
  • Patients have been treated with other trial medications in the past 2 weeks;
  • 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);
  • Women of childbearing age who are not willing to take effective contraception during treatment;
  • There are serious non-malignant tumor comorbidities that may affect long-term follow-up;
  • Patients have family history of endometrial, ovarian or other gynecologic malignancies;
  • Transvaginal ultrasound suggested more serious ovarian abnormalities or endometrial thickening;
  • 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;
  • Serious liver insufficiency with Child-Pugh C grade;
  • Serious cardiac insufficiency with New York Heart Association (NYHA) grade ≥III;
  • Patients are known severely allergic to study drug;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

Southwest Hospital, China

Chongqing, Chongqing Municipality, China

RECRUITING

Union hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

RECRUITING

Hainan People's Hospital

Haikou, Hainan, China

RECRUITING

Hebei Tumor Hospital

Shijiazhuang, Hebei, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Wuhan Tongji Hospital

Wuhan, Hubei, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

RECRUITING

The Third Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

First Hospital of China Medical University

Shenyang, Lining, China

RECRUITING

First Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

The Third Affiliated Hospital of Kunming Medical College

Kunming, Yunnan, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

TamoxifenToremifene

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Zhimin Shao, Master

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhimin Shao, M. D.

CONTACT

13611709888zhimingshao@yahoo.com

Ayong Cao, M. D.

CONTACT

18017317218caca_163@sina.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

November 22, 2017

Study Start

November 1, 2017

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 22, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(21)