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.
Study Type
OBSERVATIONAL
Enrollment
75
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Mater Hospital Sydney
Sydney, New South Wales, Australia
Lyell McEwin Hospital
Adelaide, South Australia, Australia
Icon Cancer Centre
Hobart, Tasmania, Australia
Eastern Health
Box Hill, Victoria, Australia
Monash Health
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Washington, Australia
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)
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