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NCT07465172 · ClinicalTrials.gov registry record · NA
GDF-15 and Its Relationship With Treatment-related ADverse Events in Breast Cancer
A NA study, sponsored by Breast Cancer Trials, Australia and New Zealand.
- Not yet
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT07465172: Clinical Trial NA study, sponsored by Breast Cancer Trials, Australia and New Zealand.
NCT07465172 is a NA study that has not yet begun recruiting, run by Breast Cancer Trials, Australia and New Zealand. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07465172, a NA study, has not yet begun recruiting, sponsored by Breast Cancer Trials, Australia and New Zealand.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
Study Summary
GRADE is trying to find out if there is a link between a hormone called GDF-15 and the side effects that people can experience when taking T-DXd. GDF-15 can be measured in the blood. GDF-15 levels in the blood will go up when the body is stressed under certain conditions, including breast cancer. There is a link between high GDF-15 levels and the nausea and vomiting experienced with "morning sickness" in pregnancy. It has also been shown that GDF-15 levels will go up with the use of other types of chemotherapy that are known to cause nausea and vomiting. Side effects such as feeling sick (nausea), vomiting and weight loss are common with T-DXd. Sometimes, these can be so severe that treatment needs to be stopped early. The investigators can't predict who will get bad side effects and who will not. If the investigators can find out if there is a link between GDF-15 and the side effects of T-DXd, they can use this information in future clinical trials.
Primary Outcome
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.
Interventions
- OTHER Blood collection for GDF-15
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2026-03 |
| Est. Completion | 2028-09 |
| Phase | NA |
What is known before NCT07465172 opens enrollment
NCT07465172 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Blood collection for GDF-15 is the first listed.
NCT07465172 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07465172 about?
NCT07465172 is a clinical study titled "GDF-15 and Its Relationship With Treatment-related ADverse Events in Breast Cancer". GRADE is trying to find out if there is a link between a hormone called GDF-15 and the side effects that people can experience when taking T-DXd. GDF-15 can be measured in the blood. GDF-15 levels in the blood will go up when the body is stressed under certain conditions, including breast cancer. T...
What is the current status of trial NCT07465172?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2026-03. Estimated completion is 2028-09.
What interventions are being tested in trial NCT07465172?
The interventions under investigation include: Blood collection for GDF-15 (OTHER).
Who is sponsoring clinical trial NCT07465172?
This trial is sponsored by Breast Cancer Trials, Australia and New Zealand, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07465172's enrollment target sits among peer trials
150 661st of 2000 higher than 1,299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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