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

NCT ID: NCT02132000

Last Updated: 2014-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

3036 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2020-05-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tamoxifen

tamoxifen,20mg/day

Group Type ACTIVE_COMPARATOR

toremifene or tamoxifen

Intervention Type DRUG

toremifene

toremifene,60mg/day

Group Type EXPERIMENTAL

toremifene or tamoxifen

Intervention Type DRUG

Interventions

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toremifene or tamoxifen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fengxi Su

OTHER

Sponsor Role lead

Responsible Party

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Fengxi Su

Chief of Breast cancer center in Sun Yat-Sen Memorial Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Breast cancer center of Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yaping yang, master

Role: primary

0086-020-34071145

Other Identifiers

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BCSCO002

Identifier Type: -

Identifier Source: org_study_id

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