NCT07109817 Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer
| NCT ID | NCT07109817 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Montefiore Medical Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2026-06 |
| Primary Completion | 2029-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 116 participants in total. It began in 2026-06 with a primary completion date of 2029-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a double-blinded randomized controlled clinical trial that aims to study if desloratadine can reduce rates of peripheral neuropathy development in patients with breast cancer receiving taxane chemotherapy. Researchers will compare desloratadine to a placebo (look-alike substance with no drug) and use validated neurotoxicity and quality of life questionnaires to determine if desloratadine can be used to prevent or make taxane induced peripheral neuropathy (TPIN) symptoms better.
Eligibility Criteria
Inclusion Criteria: * Patients must have histologically confirmed breast cancer, stage I-III as per the American Joint Committee on Cancer (AJCC) 8th edition (Anatomic Staging) * Patients must be planned to receive taxane-based regimen for breast cancer (Adjuvant or neoadjuvant) of at least 12 weeks duration. Patients planned to receive taxanes in combination with other chemotherapy drugs (including platinums) are eligible. Patients planned to receive taxanes plus single or dual antiher2 therapy are also eligible. Patients planned to receive taxane-based regimen with immune checkpoint inhibitors are also allowed * Age ≥18 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%) * Patients must have an adequate organ and marrow function as defined below: * absolute neutrophil count ≥1,000/microliter (mcL) * platelets ≥100,000/mcL * total bilirubin ≤ institutional upper limit of normal (ULN) * AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN * Creatinine ≤ institutional ULN * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patients with prior diagnosis of diabetes mellitus are allowed if the patient has no peripheral neuropathy * Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants * Patients must not have received prior taxane or platinum therapy * Women of childbearing potential must have a negative pregnancy test: serum or urine beta human chorionic gonadotropin (hCG) within 14 days prior to first dose of study treatment * Potential fertile subjects must agree to use adequate contraception (double barrier methods of birth control or abstinence) prior to start of treatment, for the duration of treatment, and 28 days after last study medication dose. If male, must also agree to refrain from donating sperm during this period Exclusion Criteria: * Patients with prior diagnosis of peripheral neuropathy * Patients who received chemotherapy for the current breast cancer diagnosis before the planned taxane-based regimen * Patients who are receiving any other investigation agents * Patients with concurrent use of antihistamines during or for 2 days prior to the study period * History of allergic reactions attributed to compounds of similar chemical or biologic composition to desloratadine * Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous * Pregnant or breastfeeding women are not allowed in the study * Patients who are taking probiotics * Patients who are using chronic laxatives or enema * Patients who used antibiotics within 4 weeks of registration
Contact & Investigator
Jesus R Anampa, MD, MS
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT07109817 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07109817 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07109817 currently recruiting?
Yes, NCT07109817 is actively recruiting participants. Contact the research team at janampa@montefiore.org for enrollment information.
Where is the NCT07109817 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT07109817 clinical trial?
NCT07109817 is sponsored by Montefiore Medical Center. The principal investigator is Jesus R Anampa, MD, MS at Montefiore Medical Center. The trial plans to enroll 116 participants.
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