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

Conditions

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

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Breast cancer center of Sun Yat-sen Memorial Hospital
        • Contact:
        • 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
Drug: toremifene or tamoxifen
Experimental: toremifene
toremifene,60mg/day
Drug: toremifene or tamoxifen

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

Fengxi Su

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

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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