None listed
Conditions
Brief 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.
Interventions
This is a prospective study aiming to describe what happens with the ovarian function and sexual health after receiving chemotherapy and immune checkpoint inhibitor (ICI) treatment as part of standard treatment for triple negative breast cancer in premenopausal woman less than or equal to 42 years.
Chemotherapy and ICI treatment will be delivered regardless of their involvement in the FERTILE study and will be determined by their treating clinician(s).
Eligible patients will be identified by t
This is a prospective study aiming to describe what happens with the ovarian function and sexual health after receiving chemotherapy and immune checkpoint inhibitor (ICI) treatment as part of standard treatment for triple negative breast cancer in premenopausal woman less than or equal to 42 years. Chemotherapy and ICI treatment will be delivered regardless of their involvement in the FERTILE study and will be determined by their treating clinician(s). Eligible patients will be identified by their medical oncologist at one of the participating sites and informed consent will be obtained. Contraceptive and menstrual history, sexual function questionnaires and blood for biomarkers of ovarian function will be collected at 4 timepoints during the patient’s routine reviews: 1. Before the first dose of chemotherapy and ICI 2. Within 3 months after breast surgery 3. 12 months after breast surgery 4. 24 months after breast surgery Patients will also be asked to undergo an optional pelvic ultrasound to count the number of growing follicles (antral follicle count) at the following 3 timepoints: 1. Before the first dose of chemotherapy and ICI 2. 12 months after breast surgery 3. 24 months after breast surgery As patients with TNBC on chemotherapy and ICI treatment usually have routine clinic visits before treatment commencement, a few weeks after surgery and every year after surgery for surveillance, we aim to collect the additional information, questionnaires, research blood tests and optional ultrasound at the same time as their routine visits. The anticipated time needed for collection of blood for biomarkers of ovarian function is anticipated to take 10 minutes per visit, completion of contraceptive and menstrual history and sexual function questionnaires is anticipated to take 15-20 minutes per visit, and collection of ultrasound images for antral follicle count is anticipated to take 30 minutes per visit.
Sponsors
Peter MacCallum Cancer Centre
Eligibility
Sex/Gender
All
Age
18 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
1. Patient has provided written informed consent using the FERTILE Patient Information and Consent form (PICF) 2. Early-stage TNBC (definition determined as per clinicians’ discretion) 3. Female patients between 18 and 42 years of age 4. 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 5. Planned to receive gonadotrophin releasing hormone (GnRH) agonist with neoadjuvant chemotherapy
Exclusion criteria
1. Previous removal of both ovaries or ovarian ablation (such as bilateral ovarian radiotherapy) 2. Patients who have previously received immunotherapy or chemotherapy prior to registration 3. Receiving or planned to receive adjuvant endocrine therapy Note: patients using GnRH agonist for POI prevention are not excluded 4. Post-menopausal as defined by the investigator 5. History of hypogonadism. Note: Patients with a history of gynaecological conditions such as polycystic ovarian syndrome, endometriosis, adenomyosis, pelvic inflammatory disease, etc., are not excluded 6. 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
Outcome results
None listed