Not recruiting

Study Comparing Oral Paclitaxel (DHP107) and IV Paclitaxel for Patients with Recurrent or Metastatic HER2 Negative Breast Cancer

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying a type of breast cancer known as HER2-negative breast cancer, which can either come back after treatment or spread to other parts of the body. The study is comparing two forms of a cancer treatment called paclitaxel. One form is taken by mouth as an oral solution known as DHP107, and the other is given through a vein as an intravenous infusion called TAXOL. The purpose of the study is to see how well the oral form of paclitaxel works compared to the intravenous form in treating this type of breast cancer.

Participants in the study will receive either the oral or intravenous form of paclitaxel. The study will monitor how long the cancer does not get worse, which is known as progression-free survival. Other aspects being observed include how well the cancer responds to the treatment, the overall survival of participants, and the time it takes for the treatment to stop working. The study will also look at the overall control of the disease and the quality of life of the participants.

This trial is designed to provide important information about the effectiveness and safety of oral paclitaxel compared to the intravenous form. It aims to help determine if the oral form can be a suitable first-line treatment option for patients with recurrent or metastatic HER2-negative breast cancer. The study is expected to continue until November 2025.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the clinical trial, you will be asked to sign an informed consent form. This document confirms your voluntary participation and ensures you understand the trial's purpose and procedures.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of recurrent or metastatic HER2 negative breast cancer and ensuring you meet other health criteria, such as adequate blood counts and organ function.
Step 3
Randomization
You will be randomly assigned to receive either oral paclitaxel or intravenous (IV) paclitaxel. This process is random to ensure unbiased results.
Step 4
Treatment administration
If assigned to the oral paclitaxel group, you will take the medication by mouth as directed by the study team. If assigned to the IV paclitaxel group, you will receive the medication through an infusion into a vein. The dosage and frequency will be determined by the study protocol and your healthcare provider.
Step 5
Regular monitoring
Throughout the trial, you will undergo regular monitoring to assess your response to the treatment. This includes physical exams, blood tests, and imaging studies to track the progression of your cancer.
Step 6
Follow-up visits
You will have scheduled follow-up visits with the study team to discuss your progress and any side effects you may experience. These visits are crucial for ensuring your safety and the effectiveness of the treatment.
Step 7
Completion of the trial
At the end of the trial, a final assessment will be conducted to evaluate the overall impact of the treatment on your condition. You will receive information about the next steps and any additional care you may need.

Who can join the trial?

10 criteria

Participants must be at least 19 years old.
Participants must have a confirmed diagnosis of primary, recurrent, or metastatic HER2 negative breast cancer. This means the cancer does not have a protein called HER2 on its surface.
The HER2 negative status must be confirmed through specific tests on a tumor sample.
Participants must have a life expectancy of at least 12 weeks.
Participants must have an ECOG performance status of 0-1, which means they are fully active or have some symptoms but do not need bed rest during the day.
Participants must have measurable or evaluable lesions, which are areas of cancer that can be measured or assessed through medical imaging.
Participants must have adequate blood, kidney, and liver function, as determined by specific medical tests.
If participants have cancer that has spread to the brain, it must be stable for more than 4 weeks before joining the study. If they have used steroids, they must have stopped or reduced the dose to a low level for more than 4 weeks before joining.
Participants must voluntarily agree to join the study and sign a consent form.
Participants must understand and be willing to follow the study rules, as judged by the study doctor.

Who cannot join the trial?

4 criteria

Patients with other types of cancer that are not **HER2 Negative Breast Cancer**.
Patients who are not experiencing **recurrent** (cancer that has come back) or **metastatic** (cancer that has spread to other parts of the body) breast cancer.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Tolna Vármegyei Balassa János Kórház
Szekszard, Hungary

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Oral Paclitaxel (DHP107)
is a medication being tested in this clinical trial for its effectiveness in treating breast cancer that has come back or spread to other parts of the body. This form of paclitaxel is taken by mouth, which might make it more convenient for patients compared to the traditional method of receiving it through an IV. The goal is to see if taking paclitaxel orally can help stop the cancer from getting worse and to compare its effectiveness and safety to the IV version.
IV Paclitaxel
is the standard form of paclitaxel that is given through an intravenous (IV) line. It is a well-known treatment for breast cancer and works by stopping cancer cells from growing and dividing. In this trial, IV paclitaxel is used as a comparison to see how well the oral version works in treating patients with breast cancer that is either recurrent or has spread.

Paclitaxel

What is already known about the treatment

Oral Paclitaxel (DHP107) – This medication is taken by mouth and is being studied as a treatment for recurrent or metastatic HER2 negative breast cancer. It is currently in a Phase II/III clinical trial, which means it is being tested for its effectiveness and safety compared to the traditional intravenous (IV) form of paclitaxel. The main goal is to see if it can help patients live longer without their cancer getting worse. Paclitaxel works by stopping cancer cells from dividing and growing, which helps to slow down or stop the spread of cancer. It belongs to a group of drugs known as taxanes, which are used to treat various types of cancer.

Investigated diseases

Recurrent or Metastatic HER2 Negative Breast Cancer – This type of breast cancer is characterized by the absence of the human epidermal growth factor receptor 2 (HER2) protein, which influences the growth of cancer cells. In recurrent cases, the cancer returns after initial treatment, while metastatic cases involve the spread of cancer to other parts of the body beyond the breast and nearby lymph nodes. The disease progresses as cancer cells continue to grow and spread, potentially affecting organs such as the bones, liver, lungs, or brain. The progression can vary significantly among individuals, with some experiencing rapid advancement and others having slower disease development. The absence of HER2 means that certain targeted therapies are not effective, influencing the course of the disease. The focus is often on managing symptoms and slowing the spread of cancer cells.