Evaluating Ovarian Toxicity Outcomes Following Immunotherapy in Patients With Triple-Negative Breast Cancer (TNBC)

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.

NCT Number	NCT07527819
Lead Sponsor	Peter MacCallum Cancer Centre, Australia 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
Conditions	Triple Negative Breast Cancer (TNBC)
Enrollment	75 participants
Start Date	2026-04-08
Primary Completion	2031-04 (estimated)
Study Completion	2031-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-14