Young Patients With Early Breast Cancer

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06027541
Collaborator
(none)
1,000
23

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: operation

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Research of Young Patients With Early Breast Cancer
Anticipated Study Start Date :
Feb 1, 2024
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Outcome Measures

Primary Outcome Measures

  1. 5-year disease free survival (DFS) [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 Outcome Measures

  1. 5-year overall survival (OS) [5-year]

    OS: From the time of surgery to death from any cause, calculated on a monthly basis.

  2. 5-year recurrence [5-year]

    Recurrence: Recurrence in the ipsilateral breast, axillary, or supraclavicular lymph nodes comfired by pathological biopsy confirmation.

  3. 5-year metastasis [5-year]

    Metastasis: metastasis was detected by CT, MRI, nuclide scanning or ultrasound in liver, lung, bone, brain, and other areas, without being confirmed by pathology.

  4. the correlation between poor characteristics and survival [5-year]

    clinical characteristics': T stage, N stage, tumor grade, age group, with or without ovaian protection, with or without chemotherapy/radiotherapy, operation method.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT06027541
Other Study ID Numbers:
  • YEBC
First Posted:
Sep 7, 2023
Last Update Posted:
Sep 7, 2023
Last Verified:
Jan 1, 2023
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 7, 2023