Trial summary
This study aims to capture information regarding the effect of chemotherapy and immune checkpoint inhibitor (ICI) treatment for triple negative breast cancer on ovarian function and sex hormone levels.
Who is it for?
You may be eligible for this study if you are female and aged between 18 and 42 years, you have been diagnosed with triple negative breast cancer and you are planning to receive neoadjuvant chemotherapy and ICI treatment before breast surgery.
Study details
All participants who choose to enrol in this study will be asked to complete a series of questionnaires and provide blood at 4 of their scheduled treatment/follow up visits. These visits are anticipated to add 30 minutes to the scheduled visit time. Patients will also be asked to participate in an optional pelvic ultrasound at 3 of their scheduled treatment/follow up visits. These visits are anticipated to add an additional 30 minutes to the scheduled visit time. No additional or novel treatments will be offered to participants who choose to enrol in this study, this is an observational study only.
It is hoped this research will contribute important information regarding the potential toxic effects of combination chemotherapy-ICI treatment on sexual and reproductive function in patients with triple negative breast cancer who are receiving neoadjuvant chemotherapy-ICI treatment.
Trial details
Short title
FERTILE
Diagnosis
Breast cancer
Type of treatment
Medical Oncology
Locations
Who can participate
Clinical trials can have restrictive criteria of who can and can’t participate, talk to your healthcare provider if you are interested in this clinical trial.