Evaluating Ovarian Toxicity Outcomes Following Immunotherapy in Patients With Triple-Negative Breast Cancer (TNBC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 9
- 主要终点
- Premature Ovarian Insufficiency (POI) at 24 months after cessation of neoadjuvant chemotherapy-ICI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Premature Ovarian Insufficiency (POI) at 24 months after cessation of neoadjuvant chemotherapy-ICI
时间窗: 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.
次要结局
- Premature Ovarian Insufficiency (POI) at 12 months after cessation of neoadjuvant chemotherapy-ICI(12 months (±12 weeks) after cessation of neoadjuvant chemotherapy-ICI)
- Change in Anti-Müllerian Hormone (AMH) Levels(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(Baseline; at cessation of treatment; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation)
- Time to Return of Menses(Up to 24 months after cessation of treatment)
- Change in Oestradiol (E2) Levels(Baseline; at cessation of treatment; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation)
- Change in Sexual Function (EORTC QLQ-SH22 Score)(Baseline; at cessation of treatment; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation)
- Change in Inflammatory Cytokine Levels(Baseline; at cessation of treatment; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation)
- Invasive Disease-Free Survival(12 months and 24 months after cessation of treatment)
- Pregnancy Rate and Pregnancy Outcomes(Up to 24 months after cessation of treatment)
- Fertility Preservation Discussion and Uptake(Baseline (prior to commencement of neoadjuvant chemotherapy-ICI))