Young Patients With Early Breast Cancer

NCT06027541 | Active Not Recruiting

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

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.

Conditions

Breast Cancer Female

Keywords

young patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 5-year overall survival (OS)

  5-year

• 5-year recurrence

  5-year

• 5-year metastasis

  5-year

• the correlation between poor characteristics and survival

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

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

Eligibility Criteria

• Age: Up to 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients with breast cancer receiving operation in Peking Union Medical College Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

breast cancer tissue

MeSH Terms

Interventions

Surgical Procedures, Operative; Drug Therapy; Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

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

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: September 7, 2023
• Study Start: August 1, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 3, 2025

Record last verified: 2024-08

Locations

CN (1)