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

NCT05680194 | Unknown

• 1 other identifier: EEBC
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

≥65 Years Old; early breast cancer

Outcome Measures

Primary Outcomes (2)

• 5-y DFS

  5-years of disease free survival

  5 year

• 5-y BCSS

  5-year of breast cancer-specific survival

  5 year

Secondary Outcomes (4)

• 5-y OS

  5 year

• 10-y DFS

  10 year

• 10-y BCSS

  10 year

• 10-y OS

  10 year

Interventions

operation PROCEDURE

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.

Also known as: chemotherapy, radiotherapy, endocrine therapy, targeted therapy

Bisphosphonate DRUG

Bisphosphonate

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

the patients ≥65 Years Old with breast cancer who received operaion in Peking Union Medical College Hospital

You may qualify if:

• 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

You may not qualify if:

• patients with metastasis
• patietns with recurrence
• patients without pathological information

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Paraffin section

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surgical Procedures, Operative; Drug Therapy; Radiotherapy; Diphosphonates

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Ying Zhong

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Zhong

CONTACT

0086-01069158720; bakenfish@163.com

Xuefei Wang

CONTACT

0086-01069158720; 5574571@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 11, 2023
• Study Start: April 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: December 1, 2025
• Last Updated: January 11, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)