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

ConditionTriple Negative Breast Cancer (TNBC)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18-42

SponsorPeter MacCallum Cancer Centre, Australia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Post-menopausal as defined by the investigator

Trial population

Patients with early-stage TNBC who meet all the inclusion and none of the exclusion criteria will be eligible for the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

75 Participants

are grouped into 1 trial group

Group A: Premenopausal Women With Early-Stage Triple-Negative Breast Cancer

Trial outcomes

Primary outcomes

Premature Ovarian Insufficiency (POI) at 24 months 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.

Time frame

24 months (±12 weeks) after cessation of neoadjuvant chemotherapy-ICI

Secondary outcomes

Premature Ovarian Insufficiency (POI) at 12 months after cessation of neoadjuvant chemotherapy-ICI

Proportion of participants with at least one ovary in situ who meet criteria for POI, defined as amenorrhoea for ≥4 months and post-menopausal FSH level \>25 IU/L.

Time frame

12 months (±12 weeks) after cessation of neoadjuvant chemotherapy-ICI

Change in Anti-Müllerian Hormone (AMH) Levels

Absolute and percentage change in serum AMH levels from baseline to end of neoadjuvant chemotherapy-ICI, 12 months, and 24 months post-treatment cessation.

Time frame

Baseline; at cessation of treatment (within 12 weeks of last dose); 12 months (±12 weeks); and 24 months (±12 weeks) after cessation

Change in Menstrual Status

Change in menstrual pattern (including amenorrhoea, oligomenorrhoea, or regular menstruation) compared to baseline, assessed by participant report.

Time frame

Baseline; at cessation of treatment; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation

Time to Return of Menses

Time from cessation of neoadjuvant chemotherapy-ICI to first reported menstrual period in participants who experienced treatment-related amenorrhoea.

Time frame

Up to 24 months after cessation of treatment

Other outcomes

Change in Antral Follicle Count (AFC) and Ovarian Volume

Change from baseline in antral follicle count and ovarian volume measured by transvaginal ultrasound in consenting participants.

Time frame

Baseline; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation of treatment

Change in Endometrial Thickness

Change from baseline in endometrial thickness measured by transvaginal ultrasound in consenting participants.

Time frame

Baseline; 12 months (±12 weeks); and 24 months (±12 weeks) after cessation of treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peter MacCallum Cancer Centre, Australia

Lead sponsor

Hunter Medical Research Institute (HMRI)

Collaborator

Royal Melbourne Hospital, Australia

Collaborator

Monash Health

Collaborator

Eastern Health

Collaborator

Mater Hospital Sydney

Collaborator

Chris O'Brien Lifehouse

Collaborator

Lyell McEwin Hospital

Collaborator

Sir Charles Gairdner Hospital

Collaborator

Integrated Haematology and Oncology Network

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: