Trials / Recruiting
RecruitingNCT05256745
RAGE Inhibition to Decrease Cardiotoxicity in Women With Early Breast Cancer
RAGE Inhibition to Decrease Cancer Therapy Related Cardio Toxicity in Women With Early Breast Cancer
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Georgetown University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a pilot study to evaluate the effects of azeliragon to decrease cardiac toxicity from chemotherapy and the safety of azelirgaon when given with chemotherapy. The Investigators hypothesize that there will be no significant interaction with Azeliragon and chemotherapy and that targeting the RAGE pathway will decrease anthracycline related cardiotoxicity and chemotherapy related cognitive decline.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TTP488 | Each Azeliragon capsule is 5mg, and is to be taken in the morning with food as indicated in each cohort. |
| DRUG | ddAC/ddT | Dose dense doxorubicin plus cyclophosphamide followed by paclitaxel (ddAC/ddT) for 8 cycles, administered per USPI (Unites States Prescribing Information) Label |
| DRUG | TC | Docetaxel plus cyclophosphamide (TC) for 4-6 cycles, administered per USPI (Unites States Prescribing Information) Label |
| DRUG | TCHP | Docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP)for 6 cycles, administered per USPI (Unites States Prescribing Information) Label |
| DRUG | Chemotherapy regimen that includes ddAC | can include: (1) weekly carboplatin + paclitaxel + pembrolizumab followed by pembrolizumab + dose dense doxorubicin and cyclophosphamide; (2) weekly carboplatin + paclitaxel followed by dose dense doxorubicin and cyclophosphamide; (3) weekly or dose dense paclitaxel followed by dose dense doxorubicin and cyclophosphamide, administered per USPI (Unites States Prescribing Information) Label |
Timeline
- Start date
- 2023-06-06
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2022-02-25
- Last updated
- 2025-12-24
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05256745. Inclusion in this directory is not an endorsement.