Study on the Effects and Safety of PLX038 for Patients with Advanced or Metastatic Triple-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 triple-negative breast cancer, which is a form of cancer that does not have the three common receptors known to fuel most breast cancer growth. The study is testing a new treatment called PLX038, which is a solution given through an infusion into the vein. The main goal of the study is to see how effective PLX038 is in treating patients with locally advanced or metastatic triple-negative breast cancer, meaning the cancer has spread beyond the breast to other parts of the body.

Participants in the study will receive the treatment over a period of time, and researchers will monitor how the cancer responds to PLX038. The study will also look at any side effects that may occur during the treatment. The treatment period can last up to 12 months, and the researchers will assess the best tumor response within the first six months. This means they will check if the cancer has shrunk or disappeared during this time.

In addition to the main goal, the study will also explore other aspects such as how long it takes for the cancer to respond to the treatment, how long the response lasts, and the overall survival of the patients. Researchers will also investigate if certain genetic factors or biomarkers, which are substances in the body that can indicate a disease, are related to how well PLX038 works. This information will help in understanding the potential benefits and risks of using PLX038 for treating triple-negative breast cancer.

1 joining the study

Upon joining the study, the patient will receive a detailed explanation of the trial’s purpose and procedures. The patient must provide written informed consent to participate.

The patient will undergo a screening process to confirm eligibility, which includes a review of medical history and current health status.

2 treatment initiation

The patient will begin treatment with PLX038, a solution for infusion administered intravenously.

The dosage and frequency of administration will be determined by the study protocol and the patient’s specific health needs.

3 monitoring and assessments

Throughout the trial, the patient’s response to PLX038 will be closely monitored. This includes regular assessments of tumor response using imaging techniques.

The patient will also undergo routine blood tests and other evaluations to monitor for any side effects or changes in health status.

4 evaluation of treatment efficacy

The primary goal is to assess the best tumor response within the first six months of treatment, as defined by partial or complete response.

Secondary evaluations include time to response, duration of response, progression-free survival, and overall survival.

5 completion of the trial

The trial is expected to continue until December 2025, with ongoing assessments and data collection.

Upon completion, the patient will receive a summary of their participation and any relevant findings related to their treatment.

Who Can Join the Study?

Willing and able to follow the study rules and sign a form agreeing to participate before any study-related tests begin.
If the cancer has a CPS score of 10 or more, the patient must have previously received a drug called pembrolizumab, unless it was not suitable or available at the time of initial treatment.
Any side effects from previous chemotherapy or radiation should be mild, except for stable nerve damage, hair loss, or manageable chronic immune-related side effects from past treatments.
Have an ECOG performance status of 0 or 1, which means the patient is fully active or has some symptoms but can still carry out light work.
Have proper organ function, shown by specific blood test results, including:
- Enough neutrophils, a type of white blood cell.
- Hemoglobin levels of at least 9 g/dL, which is a measure of red blood cells.
- Adequate platelet count, which helps with blood clotting.
- Normal bilirubin levels, unless the patient has a condition called Gilbert’s disease.
- Normal levels of liver enzymes ALT and AST, unless there are liver metastases.
- Normal alkaline phosphatase levels, unless there are liver metastases.
- Normal serum creatinine levels or a calculated creatinine clearance of at least 50 mL/min, which indicates kidney function.
- Women who can have children must have a negative pregnancy test.
Must have health insurance or social security as required by national laws for medical research.
Must be 18 years or older.
Both females and males with confirmed breast cancer, either in the original tumor or in areas where the cancer has spread.
The cancer must be advanced or spread to other parts of the body and cannot be cured with current treatments.
The breast cancer must be triple-negative, meaning it does not have certain hormone receptors or a protein called HER2.
The cancer must be measurable according to specific guidelines called RECIST version 1.1.
Must have had previous treatments with specific drugs, including anthracycline, taxane, and sacituzumab-govitecan, unless not suitable for the patient.
Must have received at least two prior chemotherapy treatments for advanced or metastatic breast cancer.
If the patient has known gBRCA mutations, they must have been treated with a PARP inhibitor in the metastatic setting.

Who Cannot Join the Study?

Patients who have a different type of cancer than advanced or metastatic triple-negative breast cancer cannot participate. This type of cancer is a specific form of breast cancer that does not have certain receptors, making it more challenging to treat.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements that must be met.
Patients who do not meet the gender requirements for the study cannot participate. The study may be open to both males and females, but specific criteria must be met.
Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may have additional risks or challenges, such as children, pregnant women, or those with certain disabilities.

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
Institut Curie – Site Saint-Cloud	Saint-Cloud	France
Incmnlnv Cygvw	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	17.04.2024

Trial locations

Investigated drugs:

Peg-7-Ethyl-10-Hydroxycamptothecin

PLX038 is being studied for its effectiveness in treating patients with locally advanced or metastatic triple-negative breast cancer. This medication is being evaluated to see how well it works in shrinking tumors or stopping their growth in this specific type of breast cancer. The study also looks at any side effects that patients might experience while taking this medication.

Advanced or metastatic triple-negative breast cancer – This is a type of breast cancer that lacks three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. It is considered more aggressive than other types of breast cancer because it grows and spreads faster, has fewer treatment options, and tends to have a worse prognosis. The disease often progresses quickly, with cancer cells spreading to other parts of the body, such as the bones, liver, or lungs. Symptoms may include a lump or mass in the breast, changes in breast shape or size, and skin changes over the breast. As the disease advances, it can lead to more systemic symptoms like fatigue, weight loss, and pain in areas where the cancer has spread.

Trial ID:

2022-501507-27-00

Protocol code:

IC 2020-16

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects and Safety of PLX038 for Patients with Advanced or Metastatic Triple-Negative Breast Cancer

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