RAGE Inhibition to Decrease Cardiotoxicity in Women With Early Breast Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGeorgetown University
About this trial
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.
Eligibility criteria
Qualifiers
Patients must have clinical or pathologic stage I-III, histologically confirmed breast cancer, with any ER (estrogen-receptor), PR (progesterone receptors), or HER2 (human epidermal growth factor receptor 2) status who are planned to receive chemotherapy in the adjuvant or neoadjuvant setting.
Patients must have had no prior chemotherapy/radiotherapy/or systemic therapy for early stage breast cancer, or any other malignancy
Age ≥18 years.
ECOG (Eastern Cooperative Oncology Group) performance status ≤2 (Karnofsky ≥60%, see Appendix D).
Disqualifiers
Patients who have had prior chemotherapy, radiotherapy, systemic therapy, or hormonal therapy
Patients with Stage IV breast cancer
Patients who are receiving any other investigational agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to azeliragon, or the standard of care chemotherapy assigned, including: docetaxel, cyclophosphamide, carboplatin, doxorubicin, paclitaxel, trastuzumab, pertuzumab, pembrolizumab.
Trial design
Treatments tested in this trial
- TTP488
- ddAC/ddT
- TC
- TCHP
- Chemotherapy regimen that includes ddAC
Treatment groups
48 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov