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NCT05256745 · ClinicalTrials.gov registry record · Phase 1
RAGE Inhibition to Decrease Cardiotoxicity in Women With Early Breast Cancer
A Phase 1 study of Non-metastatic Breast Cancer and Cancer Related Cognitive Decline, sponsored by Georgetown University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 3
- Study locations
NCT05256745: Recruiting Phase 1 study of Non-metastatic Breast Cancer and Cancer Related Cognitive Decline, sponsored by Georgetown University.
NCT05256745 is a Phase 1 study of Non-metastatic Breast Cancer and Cancer Related Cognitive Decline that is actively recruiting participants, run by Georgetown University. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05256745, a Phase 1 study of Non-metastatic Breast Cancer and Cancer Related Cognitive Decline, is actively recruiting participants, sponsored by Georgetown University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG TTP488
- DRUG ddAC/ddT
- DRUG TC
- DRUG TCHP
- DRUG Chemotherapy regimen that includes ddAC
Study Locations (3)
District of Columbia
- Georgetown Lombardi Comprehensive Cancer Center - Washington D.C.
- Medstar Washington Hospital Center - Washington D.C.
New Jersey
- John Theurer Cancer Center at Hackensack University Medical Center - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2023-06-06 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT05256745 shows while recruiting
NCT05256745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 2 conditions, with Non-metastatic Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which TTP488 is the first listed.
NCT05256745 reports a single indexed study location in District of Columbia, New Jersey.
Frequently Asked Questions
What is clinical trial NCT05256745 about?
NCT05256745 is a clinical study titled "RAGE Inhibition to Decrease Cardiotoxicity in Women With Early Breast Cancer". 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 RA...
What is the current status of trial NCT05256745?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2023-06-06. Estimated completion is 2026-12.
What conditions does trial NCT05256745 study?
This clinical trial studies the following conditions: Non-metastatic Breast Cancer, Cancer Related Cognitive Decline.
What interventions are being tested in trial NCT05256745?
The interventions under investigation include: TTP488 (DRUG), ddAC/ddT (DRUG), TC (DRUG), TCHP (DRUG), Chemotherapy regimen that includes ddAC (DRUG).
Who is sponsoring clinical trial NCT05256745?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05256745 being conducted?
This trial has 3 study locations across District of Columbia, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-metastatic Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05256745's enrollment target sits among peer trials
48 1026th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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