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| Name | Class |
|---|---|
| Hunter Medical Research Institute (HMRI) | UNKNOWN |
| Royal Melbourne Hospital, Australia | UNKNOWN |
| Monash Health | OTHER |
| Eastern Health |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months (±12 weeks) after cessation of neoadjuvant chemotherapy-ICI |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months (±12 weeks) after cessation of neoadjuvant chemotherapy-ICI |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation of treatment |
| Change in Endometrial Thickness |
Inclusion Criteria:
Exclusion Criteria:
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Patients with early-stage TNBC who meet all the inclusion and none of the exclusion criteria will be eligible for the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Wanda Cui, BMEDSCI, MBBS | Contact | +61 3 8559 5000 | wanda.cui@petermac.org | |
| Kathya Fernando, BBiomedSc | Contact | +61 4520 89983 | kathya.fernando@petermac.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
Maybe requested for future research.
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| OTHER |
| Mater Hospital Sydney | UNKNOWN |
| Chris O'Brien Lifehouse | UNKNOWN |
| Lyell McEwin Hospital | OTHER_GOV |
| Sir Charles Gairdner Hospital | OTHER |
| Integrated Haematology and Oncology Network | OTHER |
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Peripheral blood samples will be collected and retained
| 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. |
| 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. | 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. | 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. | 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). | 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. | 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. | 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). | 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. | Baseline (prior to commencement of neoadjuvant chemotherapy-ICI) |
Change from baseline in endometrial thickness measured by transvaginal ultrasound in consenting participants. |
| Baseline; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation of treatment |
| Mater Hospital Sydney | Sydney | New South Wales | 2060 | Australia |
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| Lyell McEwin Hospital | Adelaide | South Australia | 5112 | Australia |
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| Icon Cancer Centre | Hobart | Tasmania | 7000 | Australia |
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| Eastern Health | Box Hill | Victoria | 3128 | Australia |
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| Monash Health | Clayton | Victoria | 3168 | Australia |
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| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
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| Royal Melbourne Hospital | Melbourne | Victoria | 3052 | Australia |
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| Sir Charles Gairdner Hospital | Nedlands | Washington | 6009 | Australia |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D016649 | Primary Ovarian Insufficiency |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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