Young Patients With Early Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Research of Young Patients With Early Breast Cancer

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Procedure: operation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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, GnRHa, TAM, Fulvestrant, CDK4/6 inhibitors; target therapy: trastuzumab，patuzumab, Pyrotinib.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year disease free survival (DFS) | 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. | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year overall survival (OS) | OS: From the time of surgery to death from any cause, calculated on a monthly basis. | 5-year | 
| 5-year recurrence | Recurrence: Recurrence in the ipsilateral breast, axillary, or supraclavicular lymph nodes comfired by pathological biopsy confirmation. | 5-year | 
| 5-year metastasis | Metastasis: metastasis was detected by CT, MRI, nuclide scanning or ultrasound in liver, lung, bone, brain, and other areas, without being confirmed by pathology. | 5-year | 
| the correlation between poor characteristics and survival | clinical characteristics': T stage, N stage, tumor grade, age group, with or without ovaian protection, with or without chemotherapy/radiotherapy, operation method. | 5-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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young patients