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

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What is this study about?

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.

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.

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.

3 randomization

You will be randomly assigned to receive either oral paclitaxel or intravenous (IV) paclitaxel. This process is random to ensure unbiased results.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Tolna Vármegyei Balassa János Kórház Szekszard Hungary

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Hungary Hungary
Not recruiting
11.11.2020

Trial locations

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.

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.

Trial ID:
2024-517090-24-00
Trial Phase:
Therapeutic use (Phase IV)

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