Breast Cancer FemalePhase 3NCT03351062
Efficacy of Tamoxifen Versus Toremifene in CYP2D6 IM/PM of Premenopausal Patients With ER-positive Early Breast Cancer
A Phase 3 study testing Tamoxifen and Toremifene in people with Breast Cancer Female, run by Chinese Anti-Cancer Association at 21 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Tamoxifen and Toremifene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 844 participants
- Where
- 21 sitesChina
- Study dates
- Nov 2017to Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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;
- In other cases, the researchers don't think the subjects are suitable for participate in the study.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites, 21 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Xiang Wang, M. D., 13801189130, xiangw@vip.sina.com
Xiang Wang, M. D.
- Recruiting
First Hospital of Jilin University
Changchun, Jilin
Zhimin Fan, M. D., 13904321567, fanzhimin@163.com
Zhimin Fan, M. D.
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
Lizhi Ouyang, M. D., 13548663208, ouyanglizhi@hnszlyy.com
Lizhi Ouyang, M. D.
- Recruiting
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Guosheng Ren, M. D., 13508370536, hongy_li@hotmail.com
Guosheng Ren, M. D.
- Recruiting
Southwest Hospital, China
Chongqing, Chongqing Municipality
Jun Jiang, M. D., 13508319495, haoxian821624@foxmail.com
Jun Jiang, M. D.
- Recruiting
Union hospital of Fujian Medical University
Fuzhou, Fujian
Chuangui Song, M. D., 13960709993, songchuangui@yahoo.com
Chuangui Song, M. D.
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Ning Liao, M. D., 13632333193, drliao_ning@hotmail.com
Ning Liao, M. D.
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong
Erwei Song, M. D., 13926477694, songew@mail.sysu.edu.cn
Erwei Song, M. D.
- Recruiting
Hainan People's Hospital
Haikou, Hainan
Xiaojie Zhong, M. D., 13398982966, zhongxiaojie08@163.com
Xiaojie Zhong, M. D.
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Hongjian Yang, M. D., 13957136102, yhjzlyy@163.com
Hongjian Yang, M. D.
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Da Pang, M. D., 13904637161, pangdasir@163.com
Da Pang, M. D.
- Recruiting
The Third Affiliated Hospital of Kunming Medical College
Kunming, Yunnan
Dedian Chen, M. D., 13888087308, chendedian2006@126.com
Dedian Chen, M. D.
- Recruiting
The Third Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Yali Cao, M. D., 13330108883, caoyali1964@126.com
Yali Cao, M. D.
- Recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu
Shui Wang, M. D., 13701458115, ws0801@hotmail.com
Shui Wang, M. D.
- Recruiting
First Affiliated Hospital of Qingdao University
Qingdao, Shandong
Haibo Wang, M. D., 18661805787, hbwang66@126.com
Haibo Wang, M. D.
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Zhimin Shao, M. D., 13611709888, zhimingshao@yahoo.com
Ayong Cao, M. D., 18017317218, caca_163@sina.com
- Recruiting
First Hospital of China Medical University
Shenyang, Lining
Feng Jin, M. D., 13998890665, jinfeng66cn@hotmail.com
Feng Jin, M. D.
- Recruiting
Hebei Tumor Hospital
Shijiazhuang, Hebei
Cuizhi Geng, M. D., 13503216325, gengcuizhi@hotmail.com
Cuizhi Geng, M. D.
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Jin Zhang, M. D., 18622221173, zhangjin@tjmuch.com
Jin Zhang, M. D.
- Recruiting
Wuhan Tongji Hospital
Wuhan, Hubei
Xingrui Li, M. D., 13507150698, lixingrui07@126.com
Xingrui Li, M. D.
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Shude Cui, M. D., 13803869391, cuishude1@163.com
Shude Cui, M. D.
About this study
Official title: Multicenter Prospective, Parallel-controlled Phase III Clinical Study on Comparing Efficacy of Tamoxifen Versus Toremifene in CYP2D6 Intermediate/Poor Metabolizers of Premenopausal Patients With ER-positive Early Breast Cancer
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.
Read the detailed description
STUDY BACKGROUND Breast cancer is a serious disease that threatens human health and life. Especially in China, the incidence rate is increasing year by year. According to WHO data, the incidence of breast cancer in China in 2020 will reach 214,000. Selective estrogen receptor modulators (SERMs) are a classic form of endocrine therapy for early breast cancers, but not all hormone receptor positive breast cancers benefit from specific SERMs. Numerous studies have shown that CYP2D6 variant carriers (around 50% CYP2D6 variant carriers in Chinese population) will not benefit a lot from tamoxifen, and combined use of CYP2D6 inhibitors will further affect the efficacy of tamoxifen. However, studies on another SERM drug - toremifene have shown that its metabolism and pharmacological effects are not influenced by CYP2D6 genotype or enzyme activity. Therefore, in the principle of individualized medicine, it is necessary to compare the efficacy of using tamoxifen and toremifene in CYP2D6 variant carriers in China so as to provide more guidance for clinical use.
OBJECTIVES:
- 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.
- The secondary purpose of this study includes:
- 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.
- 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.
- 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
- Breast Cancer Female
- Being tested
- Tamoxifen, Toremifene
- Keywords
- premenopausal, early breast cancer, estrogen receptor positive
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
Also called Tamoxifen citrate
Patients will be given 10mg Tamoxifen twice a day.
ToremifeneDrug
Also called fareston
Patients will be given 60mg Toremifene once a day.
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen treatment group | Active comparator | Patients in this group will receive tamoxifen treatment. Receives: Drug: Tamoxifen |
| Toremifene treatment group | Active comparator | Patients in this group will receive Toremifene treatment. Receives: Drug: Toremifene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 5 years after randomization
Secondary outcomes (3)
Overall Survival
The time period from randomization to all-cause death
Measured: Within 5 years after randomization
Adverse drug reaction
The time period from administration to adverse events (dyslipidemia, endometrial hyperplasia) with confirmed, probably and possibly relevant relationship to trial medicine.
Measured: Within 5 years after administration
Serum drug concentration
Blood level of trial medicines and their metabolites
Measured: Within 6 months after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study startNov 2017 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 844 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Anti-Cancer Association
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Henan Cancer Hospital, The First Hospital of Jilin University, Southwest Hospital, China, First Hospital of China Medical University, Guangdong Provincial People's Hospital, Harbin Medical University, First Affiliated Hospital of Chongqing Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Jiangsu Provincial People's Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Zhejiang Cancer Hospital, Tianjin Medical University Cancer Institute and Hospital, Union hospital of Fujian Medical University, Hebei Tumor Hospital, Hunan Cancer Hospital, Affiliated Hospital of Qinghai University, Wuhan TongJi Hospital, Hainan People's Hospital, The Third Affiliated Hospital of Kunming Medical College., The Third Affiliated Hospital of Nanchang University
- Responsible party
- Sponsor
- Investigators
- Zhimin Shao, Master, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351062
- Sponsor's protocol ID
- CYP2D6-1.1
- Status last verified
- Nov 2017
- First submitted
- 20 Nov 2017
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective, Parallel-controlled Phase III Clinical Study on Comparing Efficacy of Tamoxifen Versus Toremifene in CYP2D6 Intermediate/Poor Metabolizers of Premenopausal Patients With ER-positive Early Breast Cancer
- ClinicalTrials.gov ID
- NCT03351062
- Acronym / sponsor ID
- CYP2D6-1.1
- Conditions
- Breast Cancer Female
- Keywords
- premenopausal, early breast cancer, estrogen receptor positive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 844 participants (estimated)
- Lead sponsor
- Chinese Anti-Cancer AssociationUniversity, hospital or other
- Collaborators
- Fudan University, Henan Cancer Hospital, The First Hospital of Jilin University, Southwest Hospital, China, First Hospital of China Medical University, Guangdong Provincial People's Hospital, Harbin Medical University, First Affiliated Hospital of Chongqing Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Jiangsu Provincial People's Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Zhejiang Cancer Hospital, Tianjin Medical University Cancer Institute and Hospital, Union hospital of Fujian Medical University, Hebei Tumor Hospital, Hunan Cancer Hospital, Affiliated Hospital of Qinghai University, Wuhan TongJi Hospital, Hainan People's Hospital, The Third Affiliated Hospital of Kunming Medical College., The Third Affiliated Hospital of Nanchang University
- Study start
- Nov 2017 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
STUDY BACKGROUND Breast cancer is a serious disease that threatens human health and life. Especially in China, the incidence rate is increasing year by year. According to WHO data, the incidence of breast cancer in China in 2020 will reach 214,000. Selective estrogen receptor modulators (SERMs) are a classic form of endocrine therapy for early breast cancers, but not all hormone receptor positive breast cancers benefit from specific SERMs. Numerous studies have shown that CYP2D6 variant carriers (around 50% CYP2D6 variant carriers in Chinese population) will not benefit a lot from tamoxifen, and combined use of CYP2D6 inhibitors will further affect the efficacy of tamoxifen. However, studies on another SERM drug - toremifene have shown that its metabolism and pharmacological effects are not influenced by CYP2D6 genotype or enzyme activity. Therefore, in the principle of individualized medicine, it is necessary to compare the efficacy of using tamoxifen and toremifene in CYP2D6 variant carriers in China so as to provide more guidance for clinical use.
OBJECTIVES:
- 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.
- The secondary purpose of this study includes:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen treatment group | Active comparator | Drug: TamoxifenPatients in this group will receive tamoxifen treatment. |
| Toremifene treatment group | Active comparator | Drug: ToremifenePatients in this group will receive Toremifene treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (17 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamoxifenAlso: Tamoxifen citratePatients will be given 10mg Tamoxifen twice a day. | Drug | Tamoxifen treatment group |
| ToremifeneAlso: farestonPatients will be given 60mg Toremifene once a day. | Drug | Toremifene treatment group |
Primary outcome
Disease-Free Survival
Time frame: Within 5 years after randomization
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
3 secondary outcomes
Overall Survival
Time frame: Within 5 years after randomization
Adverse drug reaction
Time frame: Within 5 years after administration
Serum drug concentration
Time frame: Within 6 months after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhimin Shao, Master principal investigator
Fudan University
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamoxifen and Toremifene in people with Breast Cancer Female, run by Chinese Anti-Cancer Association at 21 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhimin Shao, M. D. (13611709888, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (time frame: Within 5 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.