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

Primary Purpose

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

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

toremifene or tamoxifen

About this trial

This is an interventional treatment trial for Breast Cancer Patients in Premenopausal

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Breast cancer center of Sun Yat-sen Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

tamoxifen

toremifene

Arm Description

tamoxifen,20mg/day

toremifene,60mg/day

Outcomes

Primary Outcome Measures

survival outcomes: disease free survival

5-year overall survival

Secondary Outcome Measures

side effects effects of therapies

the primary safety measures are Hepatic function and blood lipid

Incidence of adverse events

Adverse events including hot flashes, irregular menses and others.

Full Information

NCT ID

NCT02132000

First Posted

April 30, 2014

Last Updated

May 3, 2014

Sponsor

Fengxi Su

1. Study Identification

Unique Protocol Identification Number

NCT02132000

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

May 2020 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Fengxi Su

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3036 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

tamoxifen

Arm Type

Active Comparator

Arm Description

tamoxifen,20mg/day

Arm Title

toremifene

Arm Type

Experimental

Arm Description

toremifene,60mg/day

Intervention Type

Drug

Intervention Name(s)

toremifene or tamoxifen

Primary Outcome Measure Information:

Title

survival outcomes: disease free survival

Time Frame

up to 5 years

Title

5-year overall survival

Time Frame

up to 5 years

Secondary Outcome Measure Information:

Title

side effects effects of therapies

Description

the primary safety measures are Hepatic function and blood lipid

Time Frame

Follow-up period,up to 5 years

Title

Incidence of adverse events

Description

Adverse events including hot flashes, irregular menses and others.

Time Frame

follow-up period, up to 5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Breast cancer center of Sun Yat-sen Memorial Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact: