RAGE Inhibition to Decrease Cardiotoxicity in Women With Early Breast Cancer

Conditions

• Cancer Related Cognitive Decline
• Non-metastatic Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TTP488 — DRUG
  Each Azeliragon capsule is 5mg, and is to be taken in the morning with food as indicated in each cohort.
• ddAC/ddT — DRUG
  Dose dense doxorubicin plus cyclophosphamide followed by paclitaxel (ddAC/ddT) for 8 cycles, administered per USPI (Unites States Prescribing Information) Label
• TC — DRUG
  Docetaxel plus cyclophosphamide (TC) for 4-6 cycles, administered per USPI (Unites States Prescribing Information) Label
• TCHP — DRUG
  Docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP)for 6 cycles, administered per USPI (Unites States Prescribing Information) Label
• Chemotherapy regimen that includes ddAC — DRUG
  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

Study Details

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.

Key Dates

Start date

Jun 6, 2023

Status verified

Dec 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

48 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: TTP488 (Azeliragon) co-administered with dose dense paclitaxel (ddAC/ddT)
  Cohort 1: On day 7 of cycle 3, twelve capsules of azeliragon taken daily for 6 days, and then four capsules of Azeliragon each day continuously through the end of that cycle of chemotherapy, extending into Cycle 4 Day 2 (C4D2).
• Experimental: Cohort 2: TTP488 (Azeliragon) co-administered with TC
  TC: docetaxel and cyclophosphamide Cohort 2a (6 cycles): Cycle 5 Day 14 (C5D14), take twelve capsules of azeliragon daily for 6 days, then four capsules of Azeliragon each day continuously through the end of that cycle of chemotherapy, extending into Cycle 6 Day 2 (C6D2). Cohort 2b (4 cycles): Cycle 3 Day 14 (C3D14), take twelve capsules of azeliragon daily for 6 days, then four capsules of Azeliragon each day continuously through the end of that cycle of chemotherapy, extending into Cycle 4 Day 2 (C4D2).
• Experimental: Cohort 3: TTP488 (Azeliragon) co-administered with TCHP
  TCHP: docetaxel, carboplatin, trastuzumab, and pertuzumab Cohort 3: Cycle 5 Day 14 (C5D14), take twelve capsules of azeliragon daily for 6 days, then four capsules of Azeliragon each day continuously through the end of that cycle of chemotherapy, extending into Cycle 6 Day 2 (C6D2).
• Experimental: Cohort 4: TTP488 (Azeliragon) co-administered with chemotherapy regimen that includes ddAC
  given at the end of the chemotherapy plan \[can include: (1)weekly carboplatin + paclitaxel + pembrolizumab followed by pembrolizumab + dose dense doxorubicin and cyclophosphamide; (2) weekly carboplatin + paclitaxel followed by dose dense doxorubicin and cyclophosphamide; (3) weekly or dose dense paclitaxel followed by dose dense doxorubicin and cyclophosphamide\] Cohort 4: On day 7 of cycle 3, twelve capsules of azeliragon taken daily for 6 days, and then four capsules of Azeliragon each day continuously through the end of that cycle of chemotherapy, extending into Cycle 4 Day 2 (C4D2).

Primary Outcome Measure

Incidence of unacceptable toxicity [ Time Frame: 1 cycle (Cohort 1 and 4 each cycle is 14 days; Cohort 2 and 3 each cycle is 21 days) ]

Central Contacts

• Lana Kheir
  202-687-9016
  [email protected]

Locations (3)

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