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

NCT07527819 · tracked via the Priya Life Science Australia tracker

Sponsor

Peter MacCallum Cancer Centre, Australia

Phase

Observational

Started

2026-04-08

Last updated

2026-04-14

Condition(s) studied

Triple Negative Breast Cancer (TNBC)

Study 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

42 Years

Healthy volunteers

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. 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

Primary outcome measure(s)

Premature Ovarian Insufficiency (POI) at 24 months after cessation of neoadjuvant chemotherapy-ICI — 24 months (±12 weeks) after cessation of neoadjuvant chemotherapy-ICI
Proportion of participants with at least one ovary in situ who meet criteria for premature ovarian insufficiency (POI), defined as amenorrhoea for ≥4 months and post-menopausal follicle-stimulating hormone (FSH) level \>25 IU/L.

Trial sites (9)

Facility	City	Region
Chris O'Brien Lifehouse	Camperdown	New South Wales
Mater Hospital Sydney	Sydney	New South Wales
Lyell McEwin Hospital	Adelaide	South Australia
Icon Cancer Centre	Hobart	Tasmania
Eastern Health	Box Hill	Victoria
Monash Health	Clayton	Victoria
Peter MacCallum Cancer Centre	Melbourne	Victoria
Royal Melbourne Hospital	Melbourne	Victoria
Sir Charles Gairdner Hospital	Nedlands	Washington

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07527819 on ClinicalTrials.gov ↗ ← All trials in Australia