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

April 30, 2014
May 3, 2014
April 2014
May 2020   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT02132000 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Efficacy and Tolerability of Toremifene or Tamoxifen Therapy in Premenopausal Estrogen and Progesterone Receptor Positive Breast Cancer Patients
Not Provided

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer Patients in Premenopausal
  • Estrogen and/or Progesterone Receptor Positive
Drug: toremifene or tamoxifen
  • Active Comparator: tamoxifen
    tamoxifen,20mg/day
    Intervention: Drug: toremifene or tamoxifen
  • Experimental: toremifene
    toremifene,60mg/day
    Intervention: Drug: toremifene or tamoxifen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3036
May 2020
May 2020   (final data collection date for primary outcome measure)

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
Female
18 Years to 60 Years
No
China
 
NCT02132000
BCSCO002
Yes
Fengxi Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Fengxi Su
Not Provided
Not Provided
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP