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NCT05680194 Clinical Trial

Prospective Research for Elderly (≥65 Years Old) Early Breast Cancer Patients

Breast Cancer Female Clinical Trial

— EEBC  

Official title:
Prospective Research for Elderly (≥65 Years Old) Early Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05680194
Other study ID # EEBC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date December 1, 2025

Study information
Verified date June 2022
Source Peking Union Medical College Hospital
Contact Ying Zhong
Phone 0086-01069158720
Email bakenfish@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 1, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers No
Gender Female
Age group 65 Years to 100 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - patients with metastasis - patietns with recurrence - patients without pathological information

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• operation
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.
Drug:
• Bisphosphonate
Bisphosphonate

Locations
Country Name City State
China Peking Union Medical College Hospital Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 5-y DFS 5-years of disease free survival 5 year
Primary 5-y BCSS 5-year of breast cancer-specific survival 5 year
Secondary 5-y OS 5-year overall survival 5 year
Secondary 10-y DFS 10-years of disease free survival 10 year
Secondary 10-y BCSS 10-year of breast cancer-specific survival 10 year
Secondary 10-y OS 10-year overall survival 10 year
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