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Study of brimonidine tartrate gel to prevent nerve damage in breast cancer patients receiving taxane treatment

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study investigates the use of TAR-0520 Gel, which contains brimonidine tartrate, for preventing nerve damage caused by cancer treatments. This specific type of nerve damage, called taxanes-induced peripheral neuropathy, occurs in patients receiving cancer medications known as taxanes (paclitaxel or docetaxel) during breast cancer treatment. Peripheral neuropathy can cause numbness, tingling, and pain in hands and feet.

The purpose of this research is to verify if TAR-0520 Gel is safe when applied to the skin of one hand and one foot twice daily. The gel belongs to a group of medications called alpha 2 agonists, which are substances that can affect nerve signals. During the study, participants will apply the gel for up to 36 weeks while receiving their regular cancer treatment.

The study will monitor how patients' bodies react to the gel, both at the application site and throughout the body. Healthcare providers will regularly check for any side effects and evaluate if there are any changes in nerve-related symptoms. This research will help determine if the gel could be a useful treatment option for preventing nerve damage in cancer patients.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive TAR-0520 Gel, which contains brimonidine tartrate, for local application

    The gel needs to be applied to one hand and one foot twice daily

    This treatment will be conducted alongside your regular taxane chemotherapy (paclitaxel or docetaxel) which is administered weekly

  2. Step 2

    Monitoring phase

    Your oncologist will regularly assess and grade any nervous system-related side effects

    Medical staff will monitor and record any adverse reactions or side effects that may occur

    The assessment includes checking for signs of peripheral neuropathy (nerve damage in hands and feet that may cause numbness or tingling)

  3. Step 3

    Safety evaluation

    Regular evaluations will be conducted to assess both local effects (where the gel is applied) and systemic effects (throughout your body)

    Any significant medical events or serious side effects will be documented and evaluated

    The study duration extends from July 2025 to June 2026

Who can join the trial?

7 criteria

  • Must be 18 years of age or older at the time of screening visit
  • Must have a confirmed diagnosis of breast cancer
  • Must be scheduled to receive treatment with weekly infusions of paclitaxel or docetaxel (these are types of chemotherapy medications called taxanes) as part of their cancer treatment plan
  • Can be either male or female
  • Must be able to understand and follow study procedures
  • Must be willing to use the study medication (TAR-0520 Gel) twice daily on one hand and one foot as directed
  • Must not be part of any vulnerable population groups (such as persons unable to give consent)

Who cannot join the trial?

12 criteria

  • History of allergic reactions to topical medications (medications applied to skin)
  • Open wounds, cuts, or skin infections on hands or feet where the gel would be applied
  • Current participation in other clinical trials
  • Pregnancy or breastfeeding
  • Severe skin conditions that could interfere with assessment of the treatment
  • Use of other topical treatments for neuropathy (nerve damage causing numbness, tingling or pain) in hands or feet
  • Unstable medical conditions that could affect safety assessment
  • Known hypersensitivity to any components of the study medication
  • Inability to follow study procedures or attend scheduled visits
  • Significant changes in cancer treatment plan expected during the study period
  • History of other neurological conditions that could confound study results
  • Severe peripheral neuropathy (grade 3 or higher) that requires immediate medical intervention
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Investigated drugs

  • TAR-0520 Gel

    is a topical medication being studied for its potential to prevent nerve damage (peripheral neuropathy) in breast cancer patients who are receiving taxane chemotherapy. The gel is applied directly to the skin of hands and feet. It is designed to protect the nerves from damage that commonly occurs during cancer treatment with taxanes.

  • Taxanes

    are a class of chemotherapy medications used to treat breast cancer. While effective against cancer cells, these medications can cause numbness, tingling, and pain in hands and feet as a side effect. This trial aims to test if the TAR-0520 gel can help prevent these nerve-related side effects when applied to the skin.

What is already known about the treatment

TAR-0520 - A topical gel medication currently being investigated in Phase 2a clinical trials for the prevention of peripheral neuropathy caused by taxane chemotherapy treatments. The medication is administered by applying the gel twice daily to hands and feet of breast cancer patients undergoing taxane therapy. While the exact molecular mechanism is still under investigation in clinical trials, this experimental treatment aims to prevent or reduce nerve damage in extremities that commonly occurs as a side effect of taxane-based chemotherapy. The drug belongs to the category of neuroprotective agents and is being studied specifically for its potential protective effects on peripheral nerves during cancer treatment.

Investigated diseases

Taxanes-induced peripheral neuropathy - A nerve disorder that occurs as a side effect of taxane chemotherapy drugs. The condition affects the peripheral nerves, primarily in hands and feet, causing numbness, tingling, and pain in these areas. The symptoms typically start in the fingers and toes and may gradually spread upward to hands and feet. Patients often experience decreased sensation, weakness in the affected areas, and problems with fine motor skills. The condition develops gradually as patients receive taxane treatments.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521674-33-00Protocol codeTARIAN 014Estimated enrolment30 patientsSponsorTarian Pharma

sourced from the EU Clinical Trials Register and site verification

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