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Evaluation of the usefulness and safety of goserelin plus tamoxifen as neoadjuvant hormone therapy for premenopausal patients with hormone receptor-positive breast cancer

Phase 2
Conditions
Breast cancer
Registration Number
JPRN-UMIN000003700
Lead Sponsor
St. Luke's International Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Female
Target Recruitment
55
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Patients with previous treatment for the breast cancer. (2) Patients receiving drugs having a potential influence on the status of sex hormones (hormone replacement therapy, raloxifene, etc.). (However, patients after washout for at least 2 months can be enrolled.) (3) Patients with myocardial infarction or congestive heart failure at the past history, or patients who need treatment of ischemic hear disease, arryhythmia or valvular disorder. (4) Patients with active double cancer. (5) Inflammatory breast cancer (6) Synchronous or asynchrous bilateral breast cancer. (7) Allergy for radio-enhancer (8) New test drug (9) Severe psychosomatic disease (10) Patients whom doctors judged inadequate to the enrollment of this study by other reasons.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical response
Secondary Outcome Measures
NameTimeMethod
Pathological response Safety Clinical usefulness Changing of Ki67-score Disease Free Survival
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