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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05680194
Collaborator
(none)
1,000
Enrollment
1
Location
44
Anticipated Duration (Months)
22.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Research for Elderly (≥65 Years Old) Early Breast Cancer Patients
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Outcome Measures

Primary Outcome Measures

  1. 5-y DFS [5 year]

    5-years of disease free survival

  2. 5-y BCSS [5 year]

    5-year of breast cancer-specific survival

Secondary Outcome Measures

  1. 5-y OS [5 year]

    5-year overall survival

  2. 10-y DFS [10 year]

    10-years of disease free survival

  3. 10-y BCSS [10 year]

    10-year of breast cancer-specific survival

  4. 10-y OS [10 year]

    10-year overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 100 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing China

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Ying Zhong, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05680194
Other Study ID Numbers:
  • EEBC
First Posted:
Jan 11, 2023
Last Update Posted:
Jan 11, 2023
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking Union Medical College Hospital
≥65 Years Old
early breast cancer
Additional relevant MeSH terms:
Breast Neoplasms
Diphosphonates

Study Results

No Results Posted as of Jan 11, 2023