PrognosisNCT07376681
Fertility Outcomes In Young Breast Cancer Patients And Their Prognosis And Offspring Health
An observational study of Prognosis and Fertility, run by Taizhou Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Prognosis, Fertility, Breast Cancer
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Young breast cancer (≤40years)
Who may be able to join
- Only subjects who meet all of the following inclusion criteria can be enrolled in this trial:
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: About 2 years after the start of the research
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: About 2 years after the start of the research.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrognosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Sun Yat-Sen University, Ruijin Hospital
- Responsible party
- Principal investigator, Zhang Yuzhu, Taizhou Hospital
- Investigators
- Yuzhu Zhang, Principal investigator, Taizhou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376681
- Sponsor's protocol ID
- ZYuzhu
- Status last verified
- Jan 2026
- First submitted
- 26 Nov 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Outcomes In Young Breast Cancer Patients And Their Prognosis And Offspring Health
- ClinicalTrials.gov ID
- NCT07376681
- Acronym / sponsor ID
- ZYuzhu
- Conditions
- Prognosis, Fertility, Breast Cancer, Young People
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Taizhou HospitalUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Sun Yat-Sen University, Ruijin Hospital
- Study start
- Jan 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young breast cancer (≤40years)
Key inclusion criteria (4 listed)
- Only subjects who meet all of the following inclusion criteria can be enrolled in this trial:
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The overall-surviva(OS) period of childbirth after diagnosis
Time frame: About 2 years after the start of the research.
The starting time of OS regarded as after completing the childbearing behavior.Death is regarded as the end time of OS.
The disease-free survival(DFS) period of childbirth after diagnosis
Time frame: About 2 years after the start of the research
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.
The growth and development of offspring
Time frame: About 2 years after the start of the research
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.
The occurrence of diseases in the descendants of young breast cancer patients.
Time frame: About 2 years after the start of the research
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
4 secondary outcomes
Fertility rate of young breast cancer patients.
Time frame: About 2 years after the start of the research.
Complications during pregnancy after diagnosis of young breast cancer patients.
Time frame: About 2 years after the start of the research
The use of fertility preservation in the reproductive process of young breast cancer patients.
Time frame: About 2 years after the start of the research
Breastfeeding.
Time frame: About 2 years after the start of the research.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuzhu Zhang principal investigator
Taizhou Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prognosis and Fertility, run by Taizhou Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall-surviva(OS) period of childbirth after diagnosis (time frame: About 2 years after the start of the research.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.