NCT07527819Not yet recruiting
Evaluating Ovarian Toxicity Outcomes Following Immunotherapy in Patients With Triple-Negative Breast Cancer (TNBC)
Source: ClinicalTrials.gov · Last updated 14 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 75 (estimated)
- First submitted
- 7 Apr 2026
- Start date
- 8 Apr 2026
- Primary completion date
- Apr 2031
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- NCT number
- NCT07527819
What you commit to
- Study type: Observational
- Planned participants: 75
- From 8 Apr 2026 to the primary completion date, Apr 2031
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous removal of both ovaries or ovarian ablation (such as bilateral ovarian radiotherapy)
- Patients who have previously received immunotherapy or chemotherapy prior to registration
- Receiving or planned to receive adjuvant endocrine therapy Note: patients using GnRH agonist for POI prevention are not excluded
Other illness
- 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
Other
- Post-menopausal as defined by the investigator
Who the study is looking for
- Patient has provided written informed consent using the FERTILE Patient Information and Consent form (PICF)
- Early-stage TNBC (definition determined as per clinicians' discretion)
- Female patients between 18 and 42 years of age
- 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
- Planned to receive gonadotrophin releasing hormone (GnRH) agonist with neoadjuvant chemotherapy
Age in the registry: 18 years to 42 years · Sex: Female · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lyell McEwin Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Eastern Health Coordinator of this site? Confirm its status | Box Hill | Australia | Unknown status |
| Chris O'Brien Lifehouse Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Icon Cancer Centre Coordinator of this site? Confirm its status | Hobart | Australia | Unknown status |
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Sir Charles Gairdner Hospital Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Mater Hospital Sydney Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.