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New tool could help breast cancer patients know their fertility future

NCT ID NCT07497191

Knowledge-focused Sponsor: Shengjing Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study will follow 300 women aged 45-55 with hormone receptor-positive breast cancer to see if changes in a hormone called AMH can predict when they will reach menopause. Researchers will collect blood samples at seven time points and track menstrual patterns. The goal is to create a model that helps doctors decide on treatments like hormone therapy and fertility preservation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple blood test that helps doctors choose the best hormone therapy and fertility preservation options for perimenopausal breast cancer patients.
What could go wrong
This is an observational study, not a treatment trial. The predictive model may not be accurate enough for widespread clinical use, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will enroll approximately 300 perimenopausal women aged 45-55 years with histologically confirmed hormone receptor-positive breast cancer treated at Liaoning Cancer Hospital. Participants will be stratified into three groups based on treatment regimen: chemotherapy plus endocrine therapy (Group A), chemotherapy plus targeted therapy plus endocrine therapy (Group B), and endocrine therapy alone (Group C). All participants must meet perimenopausal status criteria defined by menstrual history and hormone levels (FSH 10-40 IU/L, E2 \>20 pg/mL) at enrollment.

Ages

45 to 55 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female, aged 45-55 years 2. Histologically confirmed hormone receptor-positive breast cancer 3. Perimenopausal status defined as: (a) last menstrual period within 3 months prior to enrollment; and (b) FSH 10-40 IU/L and E2 \>20 pg/mL 4. Scheduled to receive adjuvant chemotherapy and/or endocrine therapy 5. Willing to undergo serial blood sampling and complete menstrual diaries 6. Able to provide written informed consent Exclusion Criteria: 1. Postmenopausal status 2. Prior bilateral oophorectomy or pelvic radiotherapy 3. Severe hepatic or renal dysfunction 4. Estrogen receptor (ER)-negative and progesterone receptor (PR)-negative breast cancer 5. Conditions affecting ovarian hormone secretion (e.g., ovarian tumors, polycystic ovary syndrome, pituitary tumors) 6. Current pregnancy, lactation, or planned pregnancy during follow-up 7. Use of hormonal intrauterine devices 8. Prior use of GnRH agonists or aromatase inhibitors

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Ovarian reserve Perimenopause

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.