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NOT YET RECRUITING
NCT07527819

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

Sponsor: Peter MacCallum Cancer Centre, Australia

View on ClinicalTrials.gov

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

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