Efficacy and Tolerability of Toremifene or Tamoxifen Therapy in Premenopausal Estrogen and Progesterone Receptor Positive Breast Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Fengxi Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT02132000
First received: April 30, 2014
Last updated: May 3, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer Patients in Premenopausal
Estrogen and/or Progesterone Receptor Positive
Drug: toremifene or tamoxifen
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:

Primary Outcome Measures:
  • survival outcomes: disease free survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • 5-year overall survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • side effects effects of therapies [ Time Frame: Follow-up period,up to 5 years ] [ Designated as safety issue: Yes ]
    the primary safety measures are Hepatic function and blood lipid

  • Incidence of adverse events [ Time Frame: follow-up period, up to 5 years ] [ Designated as safety issue: Yes ]
    Adverse events including hot flashes, irregular menses and others.


Estimated Enrollment: 3036
Study Start Date: April 2014
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: tamoxifen
tamoxifen,20mg/day
Drug: toremifene or tamoxifen
Experimental: toremifene
toremifene,60mg/day
Drug: toremifene or tamoxifen

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02132000

Locations
China, Guangdong
Breast cancer center of Sun Yat-sen Memorial Hospital Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Yaping yang, master    0086-020-34071145    yypapple1225@163.com   
Principal Investigator: Fengxi Su, Doctor         
Sub-Investigator: Weijuan Jia, Doctor         
Sub-Investigator: Ran Gu, Doctor         
Sub-Investigator: Yaping Yang, Master         
Sponsors and Collaborators
Fengxi Su
  More Information

No publications provided

Responsible Party: Fengxi Su, Chief of Breast cancer center in Sun Yat-Sen Memorial Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02132000     History of Changes
Other Study ID Numbers: BCSCO002
Study First Received: April 30, 2014
Last Updated: May 3, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Toremifene
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on July 22, 2014