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

Breast Cancer Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04440683
• Other study ID #: 20190701041GH
• Status: Recruiting
• Start date: June 2020
• Est. completion date: June 2025

Study information

• Verified date: June 2020
• Source: Jilin University
• Contact: Di Wu, Doctor
• Phone: 0086-13504331975
• Email: w2000mail[@]sohu.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: June 2025
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Prevention

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Canceration by biopsy	Imaging suspected malignant, confirmed by pathology	1 year