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Active, Not Recruiting

NCT Number: NCT06027541

Young Patients With Early Breast Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

Up to 40 year

Sex eligibility

Female

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: chemotherapy, radiotherapy, endocrine therapy, targeted therapy, ovarian protection

Primary outcomes

  1. 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

  1. 5-year overall survival (OS)

    Time frame: 5-year

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

  2. 5-year recurrence

    Time frame: 5-year

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

  3. 5-year metastasis

    Time frame: 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

    Time frame: 5-year

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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Prospective Research of Young Patients With Early Breast Cancer

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Sep 7, 2023
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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