GDF-15 and Its Relationship With Treatment-related ADverse Events in Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood collection for GDF-15: Blood samples of 20-30mL (approximately 1-2 tablespoons in total) will be taken 4 times: * Before first treatment with T-DXd * Two times during treatment (after the first and second doses of T-DXd); and * At the end of T-DXd treatment. At each blood collection, participants will be asked about: * T-DXd side effects * Medications prescribe for T-DXd side effects * Weighed to see if their weight changes during treatment. Personal and health information will also be collected from participants: * Date of birth and age, sex, ethnicity, height, weight, and activity levels. * Details about their cancer: diagnosis, type of cancer, other treatments, and pathology results. * Details about any previous pregnancies: how many, and the severity of any nausea or vomiting experienced during these pregnancies. * Details about their best response to treatment with T-DXd. * Details about the reason they stop T-DXd treatment.

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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (4)

More Breast Cancer Trials, Australia and New Zealand trials in Australia

Other trials for the same condition