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Evaluating Ovarian Toxicity Outcomes Following Immunotherapy in Patients With Triple-Negative Breast Cancer (TNBC)
Sponsor: Peter MacCallum Cancer Centre, Australia
Summary
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.
Key Details
Gender
FEMALE
Age Range
18 Years - 42 Years
Study Type
OBSERVATIONAL
Enrollment
75
Start Date
2026-04-08
Completion Date
2031-12-31
Last Updated
2026-04-14
Healthy Volunteers
No
Conditions
Locations (9)
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