Breast Cancer FemaleEEBCNCT05680194
Prospective Research for Elderly (≥65 Years Old) Early Breast Cancer Patients
An observational study of Breast Cancer Female, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The elderly patients over 65 years old with breast cancer have concomitant diseases, poor tolerance to conventional treatment, and the specific prognosis of breast cancer is relatively good. Read more about this study
- Who is it for?
- Ages 65 to 100 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- operation and Bisphosphonate
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Dec 2025
- 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 65 to 100 years
- Women only
- No healthy volunteers
- Older adult
Study population: the patients ≥65 Years Old with breast cancer who received operaion in Peking Union Medical College Hospital
Who may be able to join
- female patients with breast cancer
- ≥65 Years Old
- patients with breast cancer received operation in Peking Union Medical College Hospital
- treatment regimen was made in Peking Union Medical College Hospital
Who cannot join
- patients with metastasis
- patietns with recurrence
- patients without pathological information
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Ying Zhong, 0086-01069158720, bakenfish@163.com
About this study
The elderly patients over 65 years old with breast cancer have concomitant diseases, poor tolerance to conventional treatment, and the specific prognosis of breast cancer is relatively good. Previous studies on breast cancer have almost excluded elderly breast cancer patients, and conventional treatment schemes cannot meet the clinical diagnosis and treatment needs of elderly breast cancer patients. The establishment of a prognosis model for elderly breast cancer patients can provide personalized treatment programs. This is important for prolonging the survival time of patients and improving the quality of life. This project plans to observe the relationship between prognosis and pathological staging, molecular typing, and concomitant diseases of elderly breast cancer patients in combination with immune genes, and establish a prognosis model of elderly breast cancer and verify it. This project is expected to establish a new prognostic model for elderly breast cancer patients, accurately judge the prognosis of patients, and provide a new basis for hierarchical and personalized treatment of elderly breast cancer.
- Conditions
- Breast Cancer Female
- Being tested
- operation, Bisphosphonate
- Keywords
- ≥65 Years Old, early breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
operationProcedure or surgery
Also called chemotherapy, radiotherapy, endocrine therapy, targeted therapy
operation methods: breast-conserving surgery, mastectomy, axillary lymph node dissection, sentinal lymphnodes biopsy; chemotherapy regimens: AC, TC, AC-T/P, TCrb, TAC, capecitabine; ovarian protection:GnRHa; endocrine therapy: Aromatase inhibitor, TAM, Fulvestrant, CDK4/6 inhibitors; target therapy: trastuzumab，patuzumab, Pyrotinib.
BisphosphonateDrug
Bisphosphonate
What is being measured
The primary outcome is the main question the study is designed to answer.
5-y DFS
5-years of disease free survival
Measured: 5 year
5-y BCSS
5-year of breast cancer-specific survival
Measured: 5 year
Secondary outcomes (4)
5-y OS
5-year overall survival
Measured: 5 year
10-y DFS
10-years of disease free survival
Measured: 10 year
10-y BCSS
10-year of breast cancer-specific survival
Measured: 10 year
10-y OS
10-year overall survival
Measured: 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Apr 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion1 Dec 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 FemaleStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Zhong, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680194
- Sponsor's protocol ID
- EEBC
- Acronym
- EEBC
- Status last verified
- Jun 2022
- First submitted
- 19 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- 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 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Research for Elderly (≥65 Years Old) Early Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05680194
- Acronym / sponsor ID
- EEBC / EEBC
- Conditions
- Breast Cancer Female
- Keywords
- ≥65 Years Old, early breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 11 Jan 2023 (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.
The elderly patients over 65 years old with breast cancer have concomitant diseases, poor tolerance to conventional treatment, and the specific prognosis of breast cancer is relatively good. Previous studies on breast cancer have almost excluded elderly breast cancer patients, and conventional treatment schemes cannot meet the clinical diagnosis and treatment needs of elderly breast cancer patients. The establishment of a prognosis model for elderly breast cancer patients can provide personalized treatment programs. This is important for prolonging the survival time of patients and improving the quality of life. This project plans to observe the relationship between prognosis and pathological staging, molecular typing, and concomitant diseases of elderly breast cancer patients in combination with immune genes, and establish a prognosis model of elderly breast cancer and verify it. This project is expected to establish a new prognostic model for elderly breast cancer patients, accurately judge the prognosis of patients, and provide a new basis for hierarchical and personalized treatment of elderly breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- the patients ≥65 Years Old with breast cancer who received operaion in Peking Union Medical College Hospital
Key inclusion criteria (4 listed)
- female patients with breast cancer
- ≥65 Years Old
- patients with breast cancer received operation in Peking Union Medical College Hospital
- treatment regimen was made in Peking Union Medical College Hospital
Key exclusion criteria (3 listed)
- patients with metastasis
- patietns with recurrence
- patients without pathological information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| operationAlso: chemotherapy, radiotherapy, endocrine therapy, targeted therapyoperation methods: breast-conserving surgery, mastectomy, axillary lymph node dissection, sentinal lymphnodes biopsy; chemotherapy regimens: AC, TC, AC-T/P, TCrb, TAC, capecitabine; ovarian protection:GnRHa; endocrine therapy: Aromatase inhibitor, TAM, Fulvestrant, CDK4/6 inhibitors; target therapy: trastuzumab，patuzumab, Pyrotinib. | Procedure or surgery | – |
| BisphosphonateBisphosphonate | Drug | – |
Primary outcome
5-y DFS
Time frame: 5 year
5-years of disease free survival
5-y BCSS
Time frame: 5 year
5-year of breast cancer-specific survival
4 secondary outcomes
5-y OS
Time frame: 5 year
10-y DFS
Time frame: 10 year
10-y BCSS
Time frame: 10 year
10-y OS
Time frame: 10 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- 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.
Ying Zhong principal investigator
Peking Union Medical College Hospital
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 Female, run by Peking Union Medical College Hospital 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 3 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 11 Jan 2023. 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 Ying Zhong (0086-01069158720, bakenfish@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-y DFS (time frame: 5 year). The study lists 2 primary outcomes in all. 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 11 Jan 2023.