- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02132000
Efficacy and Tolerability of Toremifene or Tamoxifen Therapy in Premenopausal Estrogen and Progesterone Receptor Positive Breast Cancer Patients
May 3, 2014 updated by: Fengxi Su
In premenopausal women, endocrine adjuvant therapy for breast cancer primarily consists of tamoxifen alone or with ovarian suppressive strategies.
Toremifene is a chlorinated derivative of tamoxifen, but with a superior risk-benefit profile.
In this trial, we sought to compare the efficacy and tolerability of toremifene and tamoxifen therapy in premenopausal patients with operable,estrogen and/or progesterone receptor positive breast cancer patients.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
3036
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- Breast cancer center of Sun Yat-sen Memorial Hospital
-
Contact:
- Yaping yang, master
- Phone Number: 0086-020-34071145
- Email: yypapple1225@163.com
-
Principal Investigator:
- Fengxi Su, Doctor
-
Sub-Investigator:
- Weijuan Jia, Doctor
-
Sub-Investigator:
- Yaping Yang, Master
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Clinical diagnosis of Breast cancer
- Received standard treatment (chemotherapy, operation, or radiotherapy)
- premenopausal
- estrogen and/or progesterone receptor positive
Exclusion Criteria:
- Metastatic tumors
- During pregnancy or lactation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: tamoxifen
tamoxifen,20mg/day
|
|
Experimental: toremifene
toremifene,60mg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
survival outcomes: disease free survival
Time Frame: up to 5 years
|
up to 5 years
|
5-year overall survival
Time Frame: up to 5 years
|
up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
side effects effects of therapies
Time Frame: Follow-up period,up to 5 years
|
the primary safety measures are Hepatic function and blood lipid
|
Follow-up period,up to 5 years
|
Incidence of adverse events
Time Frame: follow-up period, up to 5 years
|
Adverse events including hot flashes, irregular menses and others.
|
follow-up period, up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Anticipated)
May 1, 2020
Study Completion (Anticipated)
May 1, 2020
Study Registration Dates
First Submitted
April 30, 2014
First Submitted That Met QC Criteria
May 3, 2014
First Posted (Estimate)
May 6, 2014
Study Record Updates
Last Update Posted (Estimate)
May 6, 2014
Last Update Submitted That Met QC Criteria
May 3, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Tamoxifen
- Toremifene
Other Study ID Numbers
- BCSCO002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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