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Clinical Trials/NCT06027541
NCT06027541
Active, not recruiting
Not Applicable

Prospective Research of Young Patients With Early Breast Cancer

Peking Union Medical College Hospital1 site in 1 country1,000 target enrollmentAugust 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Female
Sponsor
Peking Union Medical College Hospital
Enrollment
1000
Locations
1
Primary Endpoint
5-year disease free survival (DFS)
Status
Active, not recruiting
Last Updated
9 months ago

Overview

Brief Summary

The prognosis of young patients with breast cancer is relatively poor. Chemotherapy damages ovarian function. Endocrine treatment for up to 10 years delays the childbearing time of patients. Treatment regimens in young breast cancer patients are still controversial in the following: 1. Exemption from chemotherapy based on gene prediction results; 2. Removing drugs that damage ovarian function from chemotherapy regimens; 3. Giving ovarian protection drugs during chemotherapy for patients with hormone receptor (HR)+; 4. The right time to get pregnant. In view of the above problems, the treatment scheme recommended in the guidelines cannot meet the personalized needs of young breast cancer patients. The project plans to establish a prognosis model for young patients with breast cancer, and provide the patients hierarchical and refined management, which is significant for prolonging survival time, improving quality of life, and protecting fertility. This project plans to observe the relationship between the characteristics of immune genes, pathological staging, molecular typing, treatment plans and prognosis in the cohort of young breast cancer patients, and establish a young breast cancer prognosis model and verify it. The project is expected to establish a prognosis model and provide a hierarchical and personalized precision treatment plan for young breast cancer patients, so as to prolong the survival time, improve the fertility rate, and improve the quality of life.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
February 1, 2028
Last Updated
9 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients with breast cancer received operation in Peking Union Medical College Hospital
  • age ≤40 year old and ≥20 years old
  • treatment regimen was made in Peking Union Medical College Hospital

Exclusion Criteria

  • patients without pathological information
  • patients with metastasis
  • patients with history of other malignant tumor (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous cell skin carcinoma)
  • patients with palliative resection of breast

Outcomes

Primary Outcomes

5-year disease free survival (DFS)

Time Frame: 5 year

DFS: From the time of surgery to the time of recurrence or metastasis, calculated on a monthly basis, until the most recent discovery of recurrence or metastasis.

Secondary Outcomes

  • the correlation between poor characteristics and survival(5-year)
  • 5-year recurrence(5-year)
  • 5-year metastasis(5-year)
  • 5-year overall survival (OS)(5-year)

Study Sites (1)

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