NCT07376681

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Jan 2026Oct 2026

First Submitted

Initial submission to the registry

November 26, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

November 26, 2025

Last Update Submit

January 21, 2026

Conditions

PrognosisFertilityBreast CancerYoung People

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Fertility rate of young breast cancer patients.

    About 2 years after the start of the research.

  • Complications during pregnancy after diagnosis of young breast cancer patients.

    About 2 years after the start of the research

  • The use of fertility preservation in the reproductive process of young breast cancer patients.

    About 2 years after the start of the research

  • Breastfeeding.

    About 2 years after the start of the research.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young breast cancer (≤40years)

You may qualify if:

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

You may not qualify if:

  • Anyone who has one of the following conditions cannot be included in this trial:
  • Female patients with a diagnosis age\>40 years;
  • Stage IV breast cancer at first diagnosis;
  • The presence of other reproductive system diseases caused by oligomenorrhea or amenorrhea and infertility; Loss of clinical data or loss to follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taizhou Central Hosipital

Taizhou, Zhejiang, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Yuzhu Zhang

    Taizhou Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending doctor

Study Record Dates

First Submitted

November 26, 2025

First Posted

January 29, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations

CN(1)