Fertility Decision and Outcomes in Young Women With Breast Cancer

NCT07804745 | Active Not Recruiting

• 1 other identifier: 2025-1408
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

This observational study is to learn about the fertility outcomes and decision after breast cancer diagnosis, and the current status of fertility consultation and decision support in young women diagnosed with breast cancer in China.

Conditions

Breast Cancer - Female; Fertility

Keywords

Breast Cancer; Fertility; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Childbearing after breast cancer diagnosis

  The investigators will follow up with patients who had not given birth before their cancer diagnosis, to establish whether they had given birth by the end of follow-up. It will be assessed by patient self-report during follow-up and available medical records. The outcome will be recorded as a binary variable (yes/no).

  Up to 2026

Secondary Outcomes (2)

• Fertility preservation measures uptake

  up to 2026

• Multidisciplinary collaboration involvement

  up to 2026

Study Arms (2)

Case Group (No childbearing after diagnosis)

Patients diagnosed with breast cancer who had no live birth prior to diagnosis but had no live birth after diagnosis.

Other: No intervention (observational study)

Control Group (Childbearing after diagnosis)

Patients diagnosed with breast cancer who had no live birth prior to diagnosis but had at least one live birth after diagnosis.

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

This is an observational study. The study is based on the real-world conditions, and doesn't have any intervention.

Case Group (No childbearing after diagnosis); Control Group (Childbearing after diagnosis)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This study will include female patients aged 18-40 years who were diagnosed with breast cancer between January 2013 and December 2023 at one of three participating centres in China: the Second Affiliated Hospital of Zhejiang University School of Medicine, Jilin Cancer Hospital, and Hangzhou First People's Hospital. Eligible patients must have complete medical records and no child before cancer diagnosis. Patients with stage IV disease at diagnosis, those with pre-existing infertility factors, or those with other malignancies, will be excluded. Patients who decline to participate or cannot be contacted for follow-up will also be excluded.

You may qualify if:

• Female breast cancer patients, aged 18-40 years at diagnosis.
• Treated at the three participating hospitals between 1 January 2013 and 31 December 2023.
• Complete clinical documentation available in the electronic medical record system.
• Had no child before cancer diagnosis.

You may not qualify if:

• Prior reproductive compromise (surgical or diagnostic infertility or pre-existing infertility factors) before cancer diagnosis.
• Presented with de novo stage IV (metastatic) disease.
• Had a history of other malignancies.
• Patients who refuse to participate or cannot be contacted for follow-up.

Sponsors & Collaborators

• Second Affiliated Hospital, Zhejiang University, School of Medicine: lead
• Jilin Provincial Tumor Hospital: collaborator
• First People's Hospital of Hangzhou: collaborator

Study Sites (3)

Jilin Cancer Hospital

Changchun, Jilin, China

Location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Location

the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start: October 15, 2025
• Primary Completion: September 1, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

CN (3)