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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02132000
Recruitment Status : Recruiting
First Posted : May 6, 2014
Last Update Posted : May 6, 2014
Information provided by (Responsible Party):
Fengxi Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3036 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: tamoxifen
Drug: toremifene or tamoxifen
Experimental: toremifene
Drug: toremifene or tamoxifen

Primary Outcome Measures :
  1. survival outcomes: disease free survival [ Time Frame: up to 5 years ]
  2. 5-year overall survival [ Time Frame: up to 5 years ]

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

  2. Incidence of adverse events [ Time Frame: follow-up period, up to 5 years ]
    Adverse events including hot flashes, irregular menses and others.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02132000

China, Guangdong
Breast cancer center of Sun Yat-sen Memorial Hospital Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Yaping yang, master    0086-020-34071145   
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

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 Identifier: NCT02132000     History of Changes
Other Study ID Numbers: BCSCO002
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014

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