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New study to reveal hidden toll of breast cancer drugs on fertility

NCT ID NCT07527819

Knowledge-focused Sponsor: Peter MacCallum Cancer Centre, Australia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study will follow 75 women aged 18-42 with early-stage triple-negative breast cancer who are receiving chemotherapy plus immunotherapy before surgery. Researchers will measure hormone levels, track menstrual patterns, and use questionnaires to see how treatment affects ovarian function and fertility. No extra drugs are given—participants receive standard care. Results may help doctors better counsel patients about fertility risks.

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 research could help doctors understand the impact of these treatments on ovarian health and fertility, guiding future care and counseling for young women with breast cancer.
What could go wrong
This is an observational study, not a treatment trial. It only collects data and does not test any new therapy, so it cannot directly improve outcomes. Results may take years to influence practice.

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 75 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

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

Patients with early-stage TNBC who meet all the inclusion and none of the exclusion criteria will be eligible for the study.

Ages

18 to 42 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. Patient has provided written informed consent using the FERTILE Patient Information and Consent form (PICF) 2. Early-stage TNBC (definition determined as per clinicians' discretion) 3. Female patients between 18 and 42 years of age 4. Planned to receive at least one dose of neoadjuvant chemotherapy-ICI with a PD-(L)1 inhibitor including but not limited to pembrolizumab, atezolizumab, durvalumab or nivolumab 5. Planned to receive gonadotrophin releasing hormone (GnRH) agonist with neoadjuvant chemotherapy Exclusion Criteria: 1. Previous removal of both ovaries or ovarian ablation (such as bilateral ovarian radiotherapy) 2. Patients who have previously received immunotherapy or chemotherapy prior to registration 3. Receiving or planned to receive adjuvant endocrine therapy Note: patients using GnRH agonist for POI prevention are not excluded 4. Post-menopausal as defined by the investigator 5. Presence of any psychological, social, geographical, or other condition for which, in the opinion of the site Investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

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Conditions

The condition(s) this trial relates to.

Inflammation primary ovarian failure triple-negative breast carcinoma

As listed by the trial registrant

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

Triple negative breast cancer (TNBC)

How to take part

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

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Eastern Health

    Box Hill, Victoria, 3128, Australia

  • Icon Cancer Centre

    Hobart, Tasmania, 7000, Australia

  • Lyell McEwin Hospital

    Adelaide, South Australia, 5112, Australia

  • Mater Hospital Sydney

    Sydney, New South Wales, 2060, Australia

  • Monash Health

    Clayton, Victoria, 3168, Australia

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3052, Australia

  • Sir Charles Gairdner Hospital

    Nedlands, Washington, 6009, Australia

More trials for these conditions

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