Breast Cancer PreventionNCT04440683
Antler Plate on Preventing Mammary High-risk Lesions From Malignant Development
An observational study of Breast Cancer Prevention, run by Jilin University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer Prevention
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- Jun 2020to Jun 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients need to have good compliance
Who may be able to join
- 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
Who cannot join
- Hepatorenal dysfunction, cardiovascular and cerebrovascular diseases
- Patients not suitable for this study judged by researchers
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin, 130021
Aiping Shi, Doctor, 0086-13364308696, 13364308696@163.com
Zhimin Fan, Doctor, 0086-13756661286, fanzhimn@163.com
About this study
This study aims to prove whether antler disk extract can be put into clinical practice to prevent breast precancerous lesions from developing into cancer.
Read the 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.
- Conditions
- Breast Cancer Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Antler plate group | Antler plate group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canceration by biopsy
Imaging suspected malignant, confirmed by pathology
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study startJun 2020 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiping Shi, Jilin University
- Investigators
- Aiping Shi, Doctor, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440683
- Sponsor's protocol ID
- 20190701041GH
- Status last verified
- Jun 2020
- First submitted
- 14 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antler Plate on Preventing Mammary High-risk Lesions From Malignant Development
- ClinicalTrials.gov ID
- NCT04440683
- Acronym / sponsor ID
- 20190701041GH
- Conditions
- Breast Cancer Prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Jilin UniversityUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antler plate group | – | –Antler plate group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients need to have good compliance
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Hepatorenal dysfunction, cardiovascular and cerebrovascular diseases
- Patients not suitable for this study judged by researchers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Canceration by biopsy
Time frame: 1 year
Imaging suspected malignant, confirmed by pathology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aiping Shi, Doctor principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Prevention, run by Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Di Wu, Doctor (0086-13504331975, w2000mail@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canceration by biopsy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.