Study on the Effects of INT230-6, Vinblastine Sulfate, and Cisplatin in Patients with Early Triple-Negative Breast Cancer

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for early triple-negative breast cancer (TNBC). The treatment being tested is called INT230-6, which is a solution for injection containing two active substances: vinblastine sulfate and cisplatin. These substances are known to be used in cancer treatment. The study aims to understand how well this treatment works when injected directly into the tumor.

The purpose of the study is to determine the clinical activity of intratumoral INT230-6 in patients with early TNBC. Participants in the study will receive the treatment by direct injection into their tumor, followed by additional treatment with a combination of chemotherapy and immunotherapy. The study is designed to observe the effects of this treatment approach over a period of time, with the goal of understanding its impact on the cancer.

Throughout the study, researchers will monitor the response of the cancer to the treatment, including any changes in the size of the tumor and the overall health of the participants. The study will also look at the rate of successful breast-conserving surgeries and any side effects experienced by participants. This information will help determine the effectiveness and safety of the treatment for patients with early-stage triple-negative breast cancer.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The patient will be required to provide informed consent, confirming understanding and willingness to participate in the study.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, a physical examination, and necessary tests to ensure adequate bone marrow, liver, and kidney function. A pregnancy test will be conducted for women.

3 treatment with INT230-6

The patient will receive an injection of INT230-6 directly into the tumor. This is known as an intratumoral injection. The frequency and dosage will be determined by the study team based on individual patient needs.

4 neoadjuvant chemoimmunotherapy

Following the INT230-6 treatment, the patient will receive a combination of chemotherapy and immunotherapy. This phase is called neoadjuvant treatment, which means it is given before the main treatment to shrink the tumor.

5 monitoring and follow-up

Throughout the trial, the patient will have regular follow-up visits to monitor the response to treatment and any side effects. This includes physical exams, imaging tests, and laboratory tests.

6 surgery

After completing the treatment phases, the patient will undergo surgery to remove any remaining tumor tissue. The type of surgery will depend on the response to the treatment and the patient’s condition.

7 final assessment

A final assessment will be conducted to evaluate the overall response to the treatment. This includes checking for any remaining cancer cells and assessing the patient’s recovery.

Who Can Join the Study?

Must have a new diagnosis of early triple-negative breast cancer (TNBC), which means the cancer does not have three common receptors known to fuel most breast cancer growth.
The cancer should be locally advanced but not spread to other parts of the body.
The cancer must be at certain stages as defined by the American Joint Committee on Cancer (AJCC) guidelines.
If there are multiple tumors, the one with the most advanced stage should be used to check if you can join the study. Each tumor must be confirmed as TNBC.
There must be a measurable tumor in the breast that is at least 2 cm in size, can be seen on an ultrasound, and can be injected with treatment.
Participants can be male or female and must be 18 years or older.
Must have a good general health status, which is measured by the Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. This means you are fully active or have some symptoms but do not need bed rest during the day.
Must have normal functioning of the bone marrow, liver, and kidneys.
Women must have a negative pregnancy test to ensure they are not pregnant.
Must have a healthy heart function.

Who Cannot Join the Study?

Patients with any other type of cancer besides early triple-negative breast cancer (TNBC) cannot participate.
Patients who have had previous treatment for TNBC are not eligible.
Patients with serious heart conditions are excluded.
Patients with uncontrolled infections cannot join the study.
Pregnant or breastfeeding women are not allowed to participate.
Patients with known allergies to the study medication are excluded.
Patients who are unable to comply with the study procedures are not eligible.
Patients with a history of other serious medical conditions that could interfere with the study are excluded.

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
Hopital Prive Des Cotes D’armor	Plerin	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Francois Baclesse	Caen	France
Ceymew Lypt Bdslzf	Lyon	France
Cwyuik Oimlm Laqlwkx	Lille	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.03.2025

Trial locations

Investigated drugs:

INT230-6 is a medication being tested in this clinical trial for patients with early triple-negative breast cancer (TNBC). It is given directly into the tumor, which means it is injected right where the cancer is located. The goal of using INT230-6 is to see how well it can work against the cancer by shrinking the tumor or stopping it from growing. This medication is part of a new approach to treat cancer by targeting it directly at the source.

Investigated diseases:

Triple negative breast cancer

Early 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 an aggressive form of cancer because it grows quickly and is more likely to have spread by the time it is found. The disease typically begins in the breast tissue and can spread to nearby lymph nodes. Without the presence of these receptors, the cancer does not respond to hormonal therapy or medicines that target HER-2 receptors. The progression involves the rapid growth of cancer cells, which can invade surrounding tissues. It is often detected at an early stage through imaging and physical examination.

Trial ID:

2024-512511-49-00

Protocol code:

U1111-1305-0044

NCT ID:

NCT06358573

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of INT230-6, Vinblastine Sulfate, and Cisplatin in Patients with Early Triple-Negative Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?