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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Breast Cancer; Fertility; Prognosis; Young People

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Taizhou, Zhejiang, China
      • Taizhou Central Hosipital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Young breast cancer (≤40years)

Description

Inclusion Criteria:

Only subjects who meet all of the following inclusion criteria can be enrolled in this trial:

1. Female patients diagnosed with breast cancer aged ≤ 40 years;
2. Patients with pathologically confirmed breast cancer, and TNM stage 0-III, the disease is in a stable or progressive state;
3. Complete medical records and clinical follow-up data were available. Informed consent.

Exclusion Criteria:

Anyone who has one of the following conditions cannot be included in this trial:

1. Female patients with a diagnosis age>40 years;
2. Stage IV breast cancer at first diagnosis;
3. The presence of other reproductive system diseases caused by oligomenorrhea or amenorrhea and infertility; Loss of clinical data or loss to follow-up.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The overall-surviva(OS) period of childbirth after diagnosis	The starting time of OS regarded as after completing the childbearing behavior.Death is regarded as the end time of OS.	About 2 years after the start of the research.
The disease-free survival(DFS) period of childbirth after diagnosis	The starting time of DFS is regarded as after completing the childbearing behavior.Repase or distant metastasis is regarded as the end time of DFS.	About 2 years after the start of the research
The growth and development of offspring	The growth and development of young breast cancer patients after diagnosis. By collecting their height, weight and other data, using the Lambda-Mu-Sigma method recommended by WHO, the obtained data is fitted to the offspring growth curve of young breast cancer patients and compared with the standard curve, in order to evaluate whether the patients' offspring grows abnormally.	About 2 years after the start of the research
The occurrence of diseases in the descendants of young breast cancer patients.	Descriptive research. Describe the number of serious disease events in the offspring of young breast cancer patients after diagnosis, such as the number of secondary tumors in childhood	About 2 years after the start of the research

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertility rate of young breast cancer patients.	The ratio of the number of young breast cancer patients giving birth after diagnosis to the total number of samples included.	About 2 years after the start of the research.
Complications during pregnancy after diagnosis of young breast cancer patients.	Descriptive research. Describe the complications during pregnancy after the diagnosis of young breast cancer patients, and describe the specific types and proportion of complications.	About 2 years after the start of the research
The use of fertility preservation in the reproductive process of young breast cancer patients.	Descriptive research. Count the proportion of young breast cancer patients who use fertility preservation technology during pregnancy after diagnosis.	About 2 years after the start of the research
Breastfeeding.	It mainly describes the proportion of patients breastfeeding and whether there are any difficulties due to the disease in the process.	About 2 years after the start of the research.

Collaborators and Investigators

• Sponsor: Taizhou Hospital
• Collaborators: Second Affiliated Hospital, Sun Yat-Sen University; Ruijin Hospital
• Investigators: Principal Investigator: Yuzhu Zhang, Taizhou Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: ZYuzhu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No