GDF-15 for Side Effects in Breast Cancer
(GRADE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a hormone called GDF-15 is linked to the side effects some people experience from T-DXd, a breast cancer treatment. Researchers aim to determine if blood levels of GDF-15 can predict who might suffer severe nausea, vomiting, or weight loss from the medication. Understanding this connection could enhance treatment experiences for future patients. Individuals with metastatic or advanced HER2-positive or HER2-low breast cancer who are about to start T-DXd might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve treatment experiences for future patients.
What prior data suggests that measuring GDF-15 is safe for participants?
Research has shown that GDF-15 serves as a marker to predict certain risks in patients. Some studies have found that high levels of GDF-15 link to more severe side effects from cancer treatments. For instance, higher GDF-15 levels correlate with increased nausea and vomiting, common side effects of chemotherapy. This suggests that GDF-15 might influence the body's response to cancer treatments. Although GDF-15 is not a treatment, knowing its blood levels could help predict and manage side effects in patients receiving treatments like T-DXd.12345
Why are researchers excited about this trial?
Unlike standard treatments for side effects in breast cancer, which often involve managing symptoms with medications like anti-nausea drugs or pain relievers, GDF-15 is unique because it targets a specific protein believed to be responsible for these side effects. Researchers are excited about GDF-15 because it aims to directly address the biological mechanisms causing the side effects, rather than just alleviating them. This approach has the potential to improve quality of life for patients undergoing treatments like T-DXd by reducing side effects more effectively and sustainably.
What evidence suggests that GDF-15 is linked to side effects in breast cancer treatment?
Research has shown that GDF-15 levels rise when the body experiences stress, such as during certain cancer treatments. High GDF-15 levels link to nausea and vomiting, particularly with chemotherapy. Studies suggest that higher GDF-15 levels can worsen these side effects. Additionally, GDF-15 associates with weight loss and poor appetite, common issues in cancer patients. Understanding this hormone's role might aid in predicting and managing these side effects in the future. During T-DXd treatment, participants in this trial will have blood collected to measure GDF-15 levels, potentially offering insights into managing these side effects.26789
Who Is on the Research Team?
Heath Badger
Principal Investigator
Breast Cancer Trials, Australia and New Zealand
Sherene Loi, Prof
Principal Investigator
Peter MacCallum Cancer Centre, Australia
Michelle Li, Dr
Principal Investigator
Peter MacCallum Cancer Centre, Australia
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive T-DXd treatment, with blood collection for GDF-15 measurement
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-related adverse events
Exploratory
Exploration of longitudinal change in weight and GDF-15 levels at end-of-treatment
What Are the Treatments Tested in This Trial?
Interventions
- GDF-15
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Blood collection for GDF-15 during T-DXd treatment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Breast Cancer Trials, Australia and New Zealand
Lead Sponsor
Citations
GDF-15 and Its Relationship With Treatment-related ...
The hypothesis is that there is a positive correlation between increased levels of GDF-15 and the severity of treatment-related adverse events ( ...
New Horizons with Growth Differentiation Factor 15 in Oncology
Patients with cancer often experience weight loss, loss of muscle, poor appetite, and nausea, which reduce quality of life and make it ...
Growth Differentiation Factor 15 (GDF15)-Mediated HER2 ...
We tested the hypothesis that GDF15-mediated phosphorylation of HER2 reduces the sensitivity of HER2-overexpressing breast cancer cell lines to trastuzumab.
GDF-15 is a potential candidate biomarker for an elevated ...
GDF-15 is a candidate biomarker for increased risk of cardiotoxicity in breast cancer patients receiving neoadjuvant dual anti-HER2 therapy.
Overview of growth differentiation factor 15 (GDF15) in ...
On the one hand, the overexpression of GDF15 results in lower body weight gain and fat mass, making it a potential biomarker for obesity and related metabolic ...
GDF-15 is a potential candidate biomarker for an elevated risk ...
GDF-15 is a candidate biomarker for increased risk of cardiotoxicity in breast cancer patients receiving neoadjuvant dual anti-HER2 therapy.
Baseline circulating growth differentiation factor-15 and the ...
Among patients with cancer cachexia, GDF-15 elevation was more pronounced in those with more advanced cancer, sarcopenia, and worse performance status.
A Combined Analysis of Serum Growth Differentiation Factor ...
3.2 Serum GDF-15 and CA15-3 were elevated in breast cancer. We detected increased levels of serum GDF15 (median [IQR] 625.46 [530.94] pg/mL) in BC patients ...
Growth differentiation factor-15 and prediction of cancer ...
GDF-15 is strongly associated with survival in patients with cancer, independent of the established risk factors.
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