RAGE Inhibition for Cardiotoxicity in Early Breast Cancer
This study is looking at a drug called TTP488 (azeliragon) to see if it can reduce heart problems and memory/thinking issues (cognitive decline) that can happen with chemotherapy for early breast cancer. Researchers want to know if TTP488 is safe to take with chemotherapy like ddAC/ddT, TC, TCHP, or other chemotherapy regimens. They also hope that TTP488 will protect the heart and brain during treatment. You may be able to join if you are a woman aged 18 or older with stage I-III breast cancer (any ER, PR, or HER2 status) who is planning to receive chemotherapy. The study will look at how often participants experience side effects, severe side effects, and changes to their chemotherapy schedule.
- Study design
- This is a pilot study with a planned enrollment of 48 women. It is an interventional study, meaning participants will receive a specific treatment.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints, such as incidence of toxicity and chemotherapy modifications, are measured at each cycle (14 or 21 days depending on the cohort).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
RAGE Inhibition to Decrease Cardiotoxicity in Women With Early Breast Cancer
At a glance
Conditions
Where it's being run
3 sites across 2 statesStudy leadership
- Candace Mainor, MD · PRINCIPAL_INVESTIGATOR · Georgetown University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Incidence of unacceptable toxicity1 cycle (Cohort 1 and 4 each cycle is 14 days; Cohort 2 and 3 each cycle is 21 days)
Any Adverse Event (AE) considered unrelated to chemotherapy, underlying disease, disease progression, intercurrent illness or concomitant medications/therapies resulting in the inability to tolerate the cycle of chemotherapy
- Incidence of severe AE graded according to the CTCAE v.51 cycle (Cohort 1 and 4 each cycle is 14 days; Cohort 2 and 3 each cycle is 21 days)
- Incidence of chemotherapy dose interruption, dose modification, dose discontinuation1 cycle (Cohort 1 and 4 each cycle is 14 days; Cohort 2 and 3 each cycle is 21 days)
- Change in Troponin levelCohort 1 and 4: cycle 3 and cycle 4, day 1 and day 2 of 14 day cycle; Cohort 2 and 3:cycle 5 and cycle 6, day 1 and day 2 of 21 day cycle]
• Change in troponin levels after administration of chemotherapy, in those treated with and without azeliragon.