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

NCT07527819 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2026-04-14

No results posted yet for this 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.

Conditions

  • Triple Negative Breast Cancer (TNBC)

Sponsors & Collaborators

  • Hunter Medical Research Institute (HMRI)

    collaborator UNKNOWN

  • Royal Melbourne Hospital, Australia

    collaborator UNKNOWN

  • Monash Health

    collaborator OTHER

  • Eastern Health

    collaborator OTHER

  • Mater Hospital Sydney

    collaborator UNKNOWN

  • Chris O'Brien Lifehouse

    collaborator UNKNOWN

  • Lyell McEwin Hospital

    collaborator OTHER_GOV

  • Sir Charles Gairdner Hospital

    collaborator OTHER

  • Icon Cancer Centre

    collaborator OTHER

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-08
Primary Completion
2031-04-30
Completion
2031-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07527819 on ClinicalTrials.gov