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

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What is this study about?

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.

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 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 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 Study?

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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ioleiwnz Pjakjctfbeofmwr Cilmeh Cghpma	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.07.2025

Trial locations

Investigated drugs:

Brimonidine Tartrate

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.

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 ID:

2025-521674-33-00

Protocol code:

TARIAN 014

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?