An observational study in Triple Negative Breast Cancer (TNBC), sponsored by Peter MacCallum Cancer Centre, Australia. Not yet recruiting at 9 sites in Australia. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Peter MacCallum Cancer Centre, Australia · Observational
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.
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.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.
This study's planned enrollment of 75 is below the median of 193 across 106 observational studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Peter MacCallum Cancer Centre, Australia is the lead sponsor of 82 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with early-stage TNBC who meet all the inclusion and none of the exclusion criteria will be eligible for the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 24 months (±12 weeks) after cessation of neoadjuvant chemotherapy-ICI
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.
Time frame: 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.
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
Change in menstrual pattern (including amenorrhoea, oligomenorrhoea, or regular menstruation) compared to baseline, assessed by participant report.
Time frame: 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.
Time frame: 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.
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)
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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline (prior to commencement of neoadjuvant chemotherapy-ICI)
Change in Antral Follicle Count (AFC) and Ovarian Volume
Change from baseline in antral follicle count and ovarian volume measured by transvaginal ultrasound in consenting participants.
Time frame: Baseline; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation of treatment
Change in Endometrial Thickness
Change from baseline in endometrial thickness measured by transvaginal ultrasound in consenting participants.
Time frame: Baseline; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation of treatment
Plan to share: Undecided — Maybe requested for future research.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Peter MacCallum Cancer Centre, Australia