NCT02132000

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,036

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

6.1 years

First QC Date

April 30, 2014

Last Update Submit

May 3, 2014

Conditions

Breast Cancer Patients in PremenopausalEstrogen and/or Progesterone Receptor Positive

Outcome Measures

Primary Outcomes (2)

  • survival outcomes: disease free survival

    up to 5 years

  • 5-year overall survival

    up to 5 years

Secondary Outcomes (2)

  • side effects effects of therapies

    Follow-up period,up to 5 years

  • Incidence of adverse events

    follow-up period, up to 5 years

Study Arms (2)

tamoxifen

ACTIVE COMPARATOR

tamoxifen,20mg/day

Drug: toremifene or tamoxifen

toremifene

EXPERIMENTAL

toremifene,60mg/day

Drug: toremifene or tamoxifen

Interventions

toremifene or tamoxifenDRUG
tamoxifentoremifene

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of Breast cancer
  • Received standard treatment (chemotherapy, operation, or radiotherapy)
  • premenopausal
  • estrogen and/or progesterone receptor positive

You may not qualify if:

  • Metastatic tumors
  • During pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Breast cancer center of Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Interventions

ToremifeneTamoxifen

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of Breast cancer center in Sun Yat-Sen Memorial Hospital

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 6, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations

CN(1)