CClinicalTrials.gg
Status unknownNCT02132000Updated May 6, 2014

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

A Phase 2/3 interventional study of toremifene or tamoxifen in Breast Cancer Patients in Premenopausal and Estrogen and/or Progesterone Receptor Positive, sponsored by Fengxi Su. Status unknown at 1 site in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-05-06.

Sponsored by Fengxi Su · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
3,036
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer Patients in Premenopausal
  • Estrogen and/or Progesterone Receptor Positive

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 3,036 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Fengxi Su is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

Exclusion Criteria:

  • Metastatic tumors
  • During pregnancy or lactation
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,036 participants (estimated)

Study arms

  • Active comparator
    tamoxifen

    tamoxifen,20mg/day

    Drug: toremifene or tamoxifen

  • Experimental
    toremifene

    toremifene,60mg/day

    Drug: toremifene or tamoxifen

Interventions

  • Drugtoremifene or tamoxifen
06

What researchers measure

Primary outcomes

  1. survival outcomes: disease free survival

    Time frame: up to 5 years

  2. 5-year overall survival

    Time frame: up to 5 years

Secondary outcomes

  1. side effects effects of therapies

    the primary safety measures are Hepatic function and blood lipid

    Time frame: Follow-up period,up to 5 years

  2. Incidence of adverse events

    Adverse events including hot flashes, irregular menses and others.

    Time frame: follow-up period, up to 5 years

07

Study locations

1 of 1 sites recruiting
  • Breast cancer center of Sun Yat-sen Memorial Hospital
    Guangzhou, Guangdong 510000, China
    • Yaping yang, master · Contact · yypapple1225@163.com · 0086-020-34071145
    • Fengxi Su, Doctor · Principal investigator
    • Weijuan Jia, Doctor · Sub investigator
    • Ran Gu, Doctor · Sub investigator
    • Yaping Yang, Master · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02132000
Lead sponsor
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) — Sponsor-investigator
First posted
May 6, 2014
Start date
Apr 2014
Primary completion
May 2020 (estimated)
Completion
May 2020 (estimated)
Last update
May 6, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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