Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07527819

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Triple Negative Breast Cancer (TNBC) Adnexal Diseases Breast Diseases Breast Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Inflammation Neoplasms Neoplasms by Site Ovarian Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Ovarian Insufficiency Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia

Loading trial locations.

About this study

Patients will be asked to consent to the future use of their biological samples collected during the trial. Samples will be securely stored at Peter MacCallum Cancer Centre, coded, and linked to clinical data. Patients can request sample destruction at any time, but past analyses cannot be undone.

The Sponsor or delegate will manage trial data, while sites are responsible for data entry and resolving queries. Data will be entered into REDCap, a secure system hosted by Peter MacCallum Cancer Centre. Site staff will be trained, and only authorized personnel listed on the delegation log may complete eCRFs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Primary outcomes

  1. Premature Ovarian Insufficiency (POI) at 24 months after cessation of neoadjuvant chemotherapy-ICI

    Time frame: 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.

Secondary outcomes

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

    Time frame: 12 months (±12 weeks) 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.

  2. Change in Anti-Müllerian Hormone (AMH) Levels

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

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

  3. Change in Menstrual Status

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

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

  4. Time to Return of Menses

    Time frame: Up to 24 months after cessation of treatment

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

  5. Change in Oestradiol (E2) Levels

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

    Absolute and percentage change in serum oestradiol levels from baseline to subsequent study timepoints.

  6. Change in Sexual Function (EORTC QLQ-SH22 Score)

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

    Change from baseline in sexual function and symptom scores measured using the European Organisation for Research and Treatment of Cancer Sexual Health Questionnaire (EORTC QLQ-SH22).

  7. Change in Inflammatory Cytokine Levels

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

    Absolute and percentage change in circulating inflammatory cytokines (TNF-α, IL-1, IL-6, IFN-γ, granzyme A and B) from baseline, and association with POI at 24 months.

  8. Invasive Disease-Free Survival

    Time frame: 12 months and 24 months after cessation of treatment

    Time from cessation of neoadjuvant chemotherapy-ICI to invasive breast cancer recurrence or death from any cause.

  9. Pregnancy Rate and Pregnancy Outcomes

    Time frame: Up to 24 months after cessation of treatment

    Proportion of participants who achieve pregnancy and description of pregnancy outcomes (e.g., live birth, miscarriage, termination).

  10. Fertility Preservation Discussion and Uptake

    Time frame: Baseline (prior to commencement of neoadjuvant chemotherapy-ICI)

    Proportion of participants who report fertility preservation counselling prior to treatment initiation and proportion who undergo fertility preservation procedures.

Other outcomes

  1. Change in Antral Follicle Count (AFC) and Ovarian Volume

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

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

  2. Change in Endometrial Thickness

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Wanda Cui, BMEDSCI, MBBS

CONTACT

[email protected]

+61 3 8559 5000

Kathya Fernando, BBiomedSc

CONTACT

[email protected]

+61 4520 89983

Sponsors and collaborators

Lead sponsor

Peter MacCallum Cancer Centre, Australia

Other

Collaborators

  • Chris O'Brien Lifehouse
  • Eastern Health
  • Hunter Medical Research Institute (HMRI)
  • Integrated Haematology and Oncology Network
  • Lyell McEwin Hospital
  • Mater Hospital Sydney
  • Monash Health
  • Royal Melbourne Hospital, Australia
  • Sir Charles Gairdner Hospital

Registry information

Acronym: FERTILE

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.