Breast Cancer - FemaleNCT07804745
Fertility Decision and Outcomes in Young Women With Breast Cancer
An observational study of Breast Cancer - Female and Fertility, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breast Cancer - Female, Fertility
- How many people
- 300 participants
- Where
- 3 sitesChina
- Study dates
- 15 Oct 2025to 31 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
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Jilin Cancer Hospital
Changchun, Jilin
Hangzhou First People's Hospital
Hangzhou, Zhejiang
the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
About this study
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
- Being tested
- No intervention (observational study)
- Keywords
- Breast Cancer, Fertility, Pregnancy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 2026
Secondary outcomes (2)
Fertility preservation measures uptake
The investigators will calculate the proportion of patients who underwent fertility preservation procedures in cases vs. controls.
Measured: up to 2026
Multidisciplinary collaboration involvement
The investigators will calculate the proportion of patients with multidisciplinary team discussion or referral involving reproductive medicine, gynecology, or fertility specialists.
Measured: up to 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start15 Oct 2025
- Primary completion1 Sep 2026
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer - FemaleStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jilin Provincial Tumor Hospital, First People's Hospital of Hangzhou
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804745
- Sponsor's protocol ID
- 2025-1408
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Decision and Outcomes in Young Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT07804745
- Acronym / sponsor ID
- 2025-1408
- Conditions
- Breast Cancer - Female, Fertility
- Keywords
- Breast Cancer, Fertility, Pregnancy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Jilin Provincial Tumor Hospital, First People's Hospital of Hangzhou
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 4 Sep 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group (No childbearing after diagnosis) | – | Other: No intervention (observational study)Patients diagnosed with breast cancer who had no live birth prior to diagnosis but had no live birth after diagnosis. |
| Control Group (Childbearing after diagnosis) | – | Other: No intervention (observational study)Patients diagnosed with breast cancer who had no live birth prior to diagnosis but had at least one live birth after diagnosis. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)This is an observational study. The study is based on the real-world conditions, and doesn't have any intervention. | Other | Case Group (No childbearing after diagnosis), Control Group (Childbearing after diagnosis) |
Primary outcome
Childbearing after breast cancer diagnosis
Time frame: Up to 2026
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).
2 secondary outcomes
Fertility preservation measures uptake
Time frame: up to 2026
Multidisciplinary collaboration involvement
Time frame: up to 2026
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 30 Sep 2026.
Related trials for Breast Cancer - Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer - Female and Fertility, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Childbearing after breast cancer diagnosis (time frame: Up to 2026). 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 30 Sep 2026.