NCT07376681

Fertility Outcomes In Young Breast Cancer Patients And Their Prognosis And Offspring Health

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Taizhou Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to clarify the fertility status of young breast cancer patients, verify the independent impact of fertility behavior on the prognosis of patients with different molecular types, and evaluate the association between treatment regimens and offspring health.

Detailed description

This was a multicenter retrospective study on fertility outcomes and their prognosis and offspring health in young breast cancer patients. Based on the breast cancer database, the investigators registered the baseline data of young breast cancer patients (≤40 years old), including age at initial diagnosis, molecular typing, tumor stage, treatment plan, fertility protection measures, etc., and followed up by telephone/email and other means to collect their fertility status, recurrence and offspring growth and development data. The primary endpoints were the disease-free survival (DFS), overall survival (OS) after childbirth and childrens' growth and development. The secondary endpoints were the patient's fertility live birth rate, pregnancy outcomes and complications, use of fertility preservation techniques, breastfeeding status, etc. The investigators used the Kaplan-Meier method to draw the survival curve of the patients after childbirth, and analyzed the growth trajectory of the offspring born after diagnosis by the Lambda-Mu-Sigma method, and plotted the growth and development curve.The investigators used Log-rank to test the significance of differences in pregnancy rates between variables. The investigators used Univariate Cox regression analysis to screen factors related to prognosis, and then used multivariate Cox regression analysis to adjust for potential confounding factors to clarify independent prognostic indicators of disease. Finally, descriptive analyses were performed for other secondary outcomes.

Conditions

• Prognosis
• Fertility
• Breast Cancer
• Young People

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2026-01-29
• Last updated: 2026-01-29

Locations

1 site across 1 country: China