Triple Negative Breast Cancer (TNBC)FERTILENCT07527819
Evaluating Ovarian Toxicity Outcomes Following Immunotherapy in Patients With Triple-Negative Breast Cancer (TNBC)
An observational study of Triple Negative Breast Cancer (TNBC), run by Peter MacCallum Cancer Centre, Australia at 9 sites in Australia.
Trial summary
This study aims to collect information about the effects of chemotherapy combined with immunotherapy (immune checkpoint inhibitors) for early-stage triple-negative breast cancer (TNBC) on ovarian function and fertility. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer (TNBC)
- How many people
- 75 participants
- Where
- 9 sitesAustralia
- Study dates
- 8 Apr 2026to 31 Dec 2031
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with early-stage TNBC who meet all the inclusion and none of the exclusion criteria will be eligible for the study.
Who may be able to join
- Patient has provided written informed consent using the FERTILE Patient Information and Consent form (PICF)
- Early-stage TNBC (definition determined as per clinicians' discretion)
- Female patients between 18 and 42 years of age
- 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
- Planned to receive gonadotrophin releasing hormone (GnRH) agonist with neoadjuvant chemotherapy
Who cannot join
- Previous removal of both ovaries or ovarian ablation (such as bilateral ovarian radiotherapy)
- Patients who have previously received immunotherapy or chemotherapy prior to registration
- Receiving or planned to receive adjuvant endocrine therapy Note: patients using GnRH agonist for POI prevention are not excluded
- Post-menopausal as defined by the investigator
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Australia9 sites
Lyell McEwin Hospital
Adelaide, South Australia, 5112
A/Prof Rohit Joshi, rohit.joshi@sa.gov.au
A/Prof Rohit Joshi
Eastern Health
Box Hill, Victoria, 3128
Dr Iris Tung, Iris.Tung@easternhealth.org.au
Dr Iris Tung
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Dr Sanjeev Kumar, sanjeev.kumar@lh.org.au
Dr Sanjeev Kumar
Monash Health
Clayton, Victoria, 3168
A/Prof Michelle White, michelle@mcc.net.au
A/Prof Michelle White
Icon Cancer Centre
Hobart, Tasmania, 7000
A/Prof Louise Nott, louise.nott@ths.tas.gov.au
A/Prof Louise Nott
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Dr Wanda Cui, wanda.cui@petermac.org
Dr Wanda Cui
Royal Melbourne Hospital
Melbourne, Victoria, 3052
Dr Wanda Cui, wanda.cui@petermac.org
Dr Wanda Cui
Sir Charles Gairdner Hospital
Nedlands, Washington, 6009
Dr Louisa Lo, louisa.lo@health.wa.gov.au
Dr Louisa Lo
Mater Hospital Sydney
Sydney, New South Wales, 2060
Prof Frances Boyle, frances.boyle@sydney.edu.au
Prof Frances Boyle
About this study
This study aims to collect information about the effects of chemotherapy combined with immunotherapy (immune checkpoint inhibitors) for early-stage triple-negative breast cancer (TNBC) on ovarian function and fertility.
You may be eligible for this study if you have been diagnosed with early-stage TNBC and are planning to receive neoadjuvant chemotherapy combined with immunotherapy before surgery. Additional eligibility criteria apply.
Read more
Participants who choose to enroll will be asked to complete questionnaires and provide blood samples before and after treatment to measure hormone levels related to ovarian function. Information about menstrual patterns, fertility preservation discussions, and reproductive health will also be collected. Some participants may undergo ultrasound assessments to evaluate ovarian reserve and endometrial thickness. Follow-up will continue for up to 24 months after treatment to assess long-term ovarian function.
No additional or experimental cancer treatments will be provided as part of this study. This is an observational study only, and participants will receive standard cancer treatment as recommended by their treating team.
It is hoped this research will provide important information about the potential effects of chemotherapy and immunotherapy on ovarian health and fertility in women receiving treatment for early-stage TNBC.
Read the detailed description
Patients will be asked to consent to the future use of their biological samples collected during the trial. Samples will be securely stored at Peter MacCallum Cancer Centre, coded, and linked to clinical data. Patients can request sample destruction at any time, but past analyses cannot be undone.
The Sponsor or delegate will manage trial data, while sites are responsible for data entry and resolving queries. Data will be entered into REDCap, a secure system hosted by Peter MacCallum Cancer Centre. Site staff will be trained, and only authorized personnel listed on the delegation log may complete eCRFs.
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Keywords
- Premature Ovarian Insufficiency, chemotherapy, immunotherapy, fertility, immune checkpoint inhibitors, ovarian function, ovarian toxicity, cytokines, inflammation, menopause
- Medical subject headings
- Triple Negative Breast Neoplasms, Primary Ovarian Insufficiency, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal Women With Early-Stage Triple-Negative Breast Cancer | Premenopausal women aged 18-42 years with newly diagnosed early-stage triple-negative breast cancer (TNBC) who are scheduled to receive standard-of-care neoadjuvant chemotherapy in combination with an immune checkpoint inhibitor (ICI). Participants must have at least one ovary in situ and no prior systemic therapy for their current breast cancer diagnosis. All participants will undergo serial clinical, biochemical, and patient-reported assessments of ovarian function from baseline (prior to treatment initiation) through 24 months following cessation of neoadjuvant therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Ovarian Insufficiency (POI) at 24 months after cessation of neoadjuvant chemotherapy-ICI
Proportion of participants with at least one ovary in situ who meet criteria for premature ovarian insufficiency (POI), defined as amenorrhoea for ≥4 months and post-menopausal follicle-stimulating hormone (FSH) level >25 IU/L.
Measured: 24 months (±12 weeks) after cessation of neoadjuvant chemotherapy-ICI
Secondary outcomes (10)
Premature Ovarian Insufficiency (POI) at 12 months after cessation of neoadjuvant chemotherapy-ICI
Proportion of participants with at least one ovary in situ who meet criteria for POI, defined as amenorrhoea for ≥4 months and post-menopausal FSH level >25 IU/L.
Measured: 12 months (±12 weeks) after cessation of neoadjuvant chemotherapy-ICI
Change in Anti-Müllerian Hormone (AMH) Levels
Absolute and percentage change in serum AMH levels from baseline to end of neoadjuvant chemotherapy-ICI, 12 months, and 24 months post-treatment cessation.
Measured: Baseline; at cessation of treatment (within 12 weeks of last dose); 12 months (±12 weeks); and 24 months (±12 weeks) after cessation
Change in Menstrual Status
Change in menstrual pattern (including amenorrhoea, oligomenorrhoea, or regular menstruation) compared to baseline, assessed by participant report.
Measured: Baseline; at cessation of treatment; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation
Time to Return of Menses
Time from cessation of neoadjuvant chemotherapy-ICI to first reported menstrual period in participants who experienced treatment-related amenorrhoea.
Measured: Up to 24 months after cessation of treatment
Change in Oestradiol (E2) Levels
Absolute and percentage change in serum oestradiol levels from baseline to subsequent study timepoints.
Measured: Baseline; at cessation of treatment; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation
Change in Sexual Function (EORTC QLQ-SH22 Score)
Change from baseline in sexual function and symptom scores measured using the European Organisation for Research and Treatment of Cancer Sexual Health Questionnaire (EORTC QLQ-SH22).
Measured: Baseline; at cessation of treatment; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation
Change in Inflammatory Cytokine Levels
Absolute and percentage change in circulating inflammatory cytokines (TNF-α, IL-1, IL-6, IFN-γ, granzyme A and B) from baseline, and association with POI at 24 months.
Measured: Baseline; at cessation of treatment; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation
Invasive Disease-Free Survival
Time from cessation of neoadjuvant chemotherapy-ICI to invasive breast cancer recurrence or death from any cause.
Measured: 12 months and 24 months after cessation of treatment
Pregnancy Rate and Pregnancy Outcomes
Proportion of participants who achieve pregnancy and description of pregnancy outcomes (e.g., live birth, miscarriage, termination).
Measured: Up to 24 months after cessation of treatment
Fertility Preservation Discussion and Uptake
Proportion of participants who report fertility preservation counselling prior to treatment initiation and proportion who undergo fertility preservation procedures.
Measured: Baseline (prior to commencement of neoadjuvant chemotherapy-ICI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start8 Apr 2026 (estimated)
- Primary completionApr 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast Cancer (TNBC)Studies 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
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Hunter Medical Research Institute (HMRI), Royal Melbourne Hospital, Australia, Monash Health, Eastern Health, Mater Hospital Sydney, Chris O'Brien Lifehouse, Lyell McEwin Hospital, Sir Charles Gairdner Hospital, Integrated Haematology and Oncology Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527819
- Sponsor's protocol ID
- HREC/123447/PMCC
- Acronym
- FERTILE
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Maybe requested for future research.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Ovarian Toxicity Outcomes Following Immunotherapy in Patients With Triple-Negative Breast Cancer (TNBC)
- ClinicalTrials.gov ID
- NCT07527819
- Acronym / sponsor ID
- FERTILE / HREC/123447/PMCC
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Keywords
- Premature Ovarian Insufficiency, chemotherapy, immunotherapy, fertility, immune checkpoint inhibitors, ovarian function, ovarian toxicity, cytokines
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Collaborators
- Hunter Medical Research Institute (HMRI), Royal Melbourne Hospital, Australia, Monash Health, Eastern Health, Mater Hospital Sydney, Chris O'Brien Lifehouse, Lyell McEwin Hospital, Sir Charles Gairdner Hospital, Integrated Haematology and Oncology Network
- Study start
- 8 Apr 2026 (estimated)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 14 Apr 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 study aims to collect information about the effects of chemotherapy combined with immunotherapy (immune checkpoint inhibitors) for early-stage triple-negative breast cancer (TNBC) on ovarian function and fertility.
You may be eligible for this study if you have been diagnosed with early-stage TNBC and are planning to receive neoadjuvant chemotherapy combined with immunotherapy before surgery. Additional eligibility criteria apply.
Participants who choose to enroll will be asked to complete questionnaires and provide blood samples before and after treatment to measure hormone levels related to ovarian function. Information about menstrual patterns, fertility preservation discussions, and reproductive health will also be collected. Some participants may undergo ultrasound assessments to evaluate ovarian reserve and endometrial thickness. Follow-up will continue for up to 24 months after treatment to assess long-term ovarian function.
No additional or experimental cancer treatments will be provided as part of this study. This is an observational study only, and participants will receive standard cancer treatment as recommended by their treating team.
It is hoped this research will provide important information about the potential effects of chemotherapy and immunotherapy on ovarian health and fertility in women receiving treatment for early-stage TNBC.
Detailed description
Patients will be asked to consent to the future use of their biological samples collected during the trial. Samples will be securely stored at Peter MacCallum Cancer Centre, coded, and linked to clinical data. Patients can request sample destruction at any time, but past analyses cannot be undone.
The Sponsor or delegate will manage trial data, while sites are responsible for data entry and resolving queries. Data will be entered into REDCap, a secure system hosted by Peter MacCallum Cancer Centre. Site staff will be trained, and only authorized personnel listed on the delegation log may complete eCRFs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premenopausal Women With Early-Stage Triple-Negative Breast Cancer | – | –Premenopausal women aged 18-42 years with newly diagnosed early-stage triple-negative breast cancer (TNBC) who are scheduled to receive standard-of-care neoadjuvant chemotherapy in combination with an immune checkpoint inhibitor (ICI). Participants must have at least one ovary in situ and no prior systemic therapy for their current breast cancer diagnosis. All participants will undergo serial clinical, biochemical, and patient-reported assessments of ovarian function from baseline (prior to treatment initiation) through 24 months following cessation of neoadjuvant therapy. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with early-stage TNBC who meet all the inclusion and none of the exclusion criteria will be eligible for the study.
Key inclusion criteria (5 listed)
- Patient has provided written informed consent using the FERTILE Patient Information and Consent form (PICF)
- Early-stage TNBC (definition determined as per clinicians' discretion)
- Female patients between 18 and 42 years of age
- 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
- Planned to receive gonadotrophin releasing hormone (GnRH) agonist with neoadjuvant chemotherapy
Key exclusion criteria (5 listed)
- Previous removal of both ovaries or ovarian ablation (such as bilateral ovarian radiotherapy)
- Patients who have previously received immunotherapy or chemotherapy prior to registration
- Receiving or planned to receive adjuvant endocrine therapy Note: patients using GnRH agonist for POI prevention are not excluded
- Post-menopausal as defined by the investigator
- 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
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
Premature Ovarian Insufficiency (POI) at 24 months after cessation of neoadjuvant chemotherapy-ICI
Time frame: 24 months (±12 weeks) after cessation of neoadjuvant chemotherapy-ICI
Proportion of participants with at least one ovary in situ who meet criteria for premature ovarian insufficiency (POI), defined as amenorrhoea for ≥4 months and post-menopausal follicle-stimulating hormone (FSH) level >25 IU/L.
10 secondary outcomes
Premature Ovarian Insufficiency (POI) at 12 months after cessation of neoadjuvant chemotherapy-ICI
Time frame: 12 months (±12 weeks) after cessation of neoadjuvant chemotherapy-ICI
Change in Anti-Müllerian Hormone (AMH) Levels
Time frame: Baseline; at cessation of treatment (within 12 weeks of last dose); 12 months (±12 weeks); and 24 months (±12 weeks) after cessation
Change in Menstrual Status
Time frame: Baseline; at cessation of treatment; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation
Time to Return of Menses
Time frame: Up to 24 months after cessation of treatment
Change in Oestradiol (E2) Levels
Time frame: Baseline; at cessation of treatment; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation
Change in Sexual Function (EORTC QLQ-SH22 Score)
Time frame: Baseline; at cessation of treatment; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation
Change in Inflammatory Cytokine Levels
Time frame: Baseline; at cessation of treatment; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation
Invasive Disease-Free Survival
Time frame: 12 months and 24 months after cessation of treatment
Pregnancy Rate and Pregnancy Outcomes
Time frame: Up to 24 months after cessation of treatment
Fertility Preservation Discussion and Uptake
Time frame: Baseline (prior to commencement of neoadjuvant chemotherapy-ICI)
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 14 Apr 2026.
- ANZCTR RegistrationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Maybe requested for future research.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triple Negative Breast Cancer (TNBC), run by Peter MacCallum Cancer Centre, Australia at 9 sites in Australia.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia. 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?
Contact Dr Wanda Cui, BMEDSCI, MBBS (+61 3 8559 5000, wanda.cui@petermac.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premature Ovarian Insufficiency (POI) at 24 months after cessation of neoadjuvant chemotherapy-ICI (time frame: 24 months (±12 weeks) after cessation of neoadjuvant chemotherapy-ICI). 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 14 Apr 2026.