Antler Plate on Preventing Mammary High-risk Lesions From Malignant Development

Recruiting

• Conditions: Breast Cancer Prevention

• Registration Number: NCT04440683
• Lead Sponsor: Jilin University

Brief Summary

This study aims to prove whether antler disk extract can be put into clinical practice to prevent breast precancerous lesions from developing into cancer.

Detailed Description

Through estrogen receptor antagonists, tamoxifen can reduce the risk of breast high-risk disease progression to cancer, but only reduce the probability of some ER and PR positive tumors, which has no preventive effect on triple negative breast cancer and HER-2 positive breast cancer. In the first hospital of Jilin University, the preparations containing antler ingredients have been clinically proven to be able to treat breast hyperplasia, which has been proved to be able to prevent breast cancer in basic research, and antler ingredients have been proved to be non-toxic and side effects in the treatment dose. This study aims to prove whether antler disk extract can be put into clinical practice to prevent breast precancerous lesions from developing into cancer.

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06
• Study First Submitted: 2020-06-14
• Study First Submitted QC: 2020-06-18
• Last Update Submitted: 2020-06-18
• Study First Posted: 2020-06-22
• Last Update Posted: 2020-06-22
• Primary Completion: 2022-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 6000

Inclusion Criteria

• Women between the ages of 18 and 80
• Atypical hyperplasia or / and lobular carcinoma in situ confirmed by breast histology
• Women with breast cancer in first degree relatives
• Patients have better compliance with a series of research-related behaviors such as the upcoming comprehensive treatment and follow-up, and can understand and accept the research process of this study, and sign a written informed consent

Exclusion Criteria

• Hepatorenal dysfunction, cardiovascular and cerebrovascular diseases
• Patients not suitable for this study judged by researchers

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Canceration by biopsy	1 year	Imaging suspected malignant, confirmed by pathology

Trial Locations

Locations (1)

First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China