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

Phase 2

• Conditions: Breast Cancer Patients in Premenopausal; Estrogen and/or Progesterone Receptor Positive
• Interventions: Drug: toremifene or tamoxifen

• Registration Number: NCT02132000
• Lead Sponsor: Fengxi Su

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-30
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-03
• Last Update Submitted: 2014-05-03
• Study First Posted: 2014-05-06
• Last Update Posted: 2014-05-06
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 3036

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tamoxifen	toremifene or tamoxifen	tamoxifen,20mg/day
toremifene	toremifene or tamoxifen	toremifene,60mg/day

Primary Outcome Measures

Name	Time	Method
5-year overall survival	up to 5 years
survival outcomes: disease free survival	up to 5 years

Secondary Outcome Measures

Name	Time	Method
side effects effects of therapies	Follow-up period,up to 5 years	the primary safety measures are Hepatic function and blood lipid
Incidence of adverse events	follow-up period, up to 5 years	Adverse events including hot flashes, irregular menses and others.

Trial Locations

Locations (1)

Breast cancer center of Sun Yat-sen Memorial Hospital; 🇨🇳 Guangzhou, Guangdong, China