GDF-15 and T-DXd Treatment in Breast Cancer
This study is looking at the relationship between a hormone called GDF-15 and side effects like nausea and vomiting in people with breast cancer who are taking the drug T-DXd. Researchers want to see if higher levels of GDF-15 in your blood are linked to more severe side effects. You might be able to join if you are at least 18 years old, have HER2-positive or HER2-low metastatic breast cancer, and are about to start T-DXd treatment. The study aims to understand if changes in GDF-15 levels predict how much nausea you experience before your third cycle of T-DXd. The current recruitment status is unclear, and they plan to enroll 150 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific intervention (blood collection). It plans to enroll 150 participants.
- What's involved
- You would have blood samples (about 1-2 tablespoons) taken four times: before your first T-DXd treatment, twice during treatment (after the first and second doses), and at the end of T-DXd treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint for nausea is measured from baseline to after receiving two cycles of T-DXd treatment (each cycle is 28 days).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
GDF-15 and Its Relationship With Treatment-related ADverse Events in Breast Cancer
At a glance
Conditions
Where it's being run
4 sites across 4 statesStudy leadership
- Heath Badger · STUDY_DIRECTOR · Breast Cancer Trials, Australia and New Zealand
- Sherene Loi, Prof · STUDY_CHAIR · Peter MacCallum Cancer Centre, Australia
- Michelle Li, Dr · STUDY_CHAIR · Peter MacCallum Cancer Centre, Australia
Who to contact
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What this trial measures
- Nausea prior to Cycle 3 of T-DXd, graded according to Common Terminology Criteria for Adverse Advents (CTCAE) v5.0.From baseline to after receiving 2 cycles of T-DXd treatment (each cycle is 28 days).
To investigate if the percentage change in levels of GDF-15 from baseline to after receiving 2 cycles of T-DXd is associated with moderate/high grade nausea (CTCAE Grade 2-4) experienced at this timepoint by patients with metastatic/advanced unresectable HER2-positive or HER2-low breast cancer.