Recruiting

Study on NECVAX-NEO1 and Paclitaxel Albumin-Bound for Patients with Triple-Negative Breast Cancer

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What is this trial about?

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

This clinical trial is focused on studying triple-negative breast cancer, a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth. The trial will explore the effects of a new treatment called NECVAX-NEO1, which is being tested as an additional therapy to the standard first-line treatment involving a type of medicine known as an anti-PD-1 monoclonal antibody. This standard treatment helps the immune system recognize and attack cancer cells. The trial will also involve the use of a medication called Abraxane, which is a form of chemotherapy used to treat breast cancer.

The purpose of the study is to assess the safety and tolerability of NECVAX-NEO1 when used alongside the existing treatment for triple-negative breast cancer. Participants in the study will receive the new treatment in addition to their regular therapy. The study will monitor participants over a period of time to observe any side effects and to see how well the treatment is tolerated. Participants will undergo regular check-ups, including blood tests and scans, to track their health and the progress of the cancer.

The study will also look at how the cancer responds to the treatment by examining tissue samples and measuring changes in the cancer's size and spread. The trial aims to provide valuable information on whether adding NECVAX-NEO1 to the current treatment can improve outcomes for patients with triple-negative breast cancer. The study is expected to continue until 2028, with recruitment starting in 2024.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, physical examination, and laboratory tests to ensure adequate renal, bone marrow, and hepatic function.
Imaging tests such as MRI or CT scans are performed to evaluate the tumor.
Step 2
Treatment initiation
The treatment phase begins with the administration of NECVAX-NEO1 at a dose level of 10^7 CFU. This is given in addition to a programmed cell death protein 1 (PD-1) inhibitor therapy.
The treatment includes Abraxane (paclitaxel albumin-bound) administered as a 5 mg/ml powder for dispersion for infusion.
Step 3
Treatment schedule
The treatment is administered through infusion and oral routes. The specific schedule and frequency of administration are determined by the study protocol and the healthcare team.
Step 4
Monitoring and follow-up
Throughout the treatment period, regular monitoring is conducted to assess safety and tolerability. This includes tracking any adverse events and changes in laboratory parameters, physical examinations, vital signs, and electrocardiograms (ECGs).
Follow-up assessments are scheduled to evaluate the response to treatment, including imaging tests and laboratory evaluations.
Step 5
Surgery and evaluation
After the completion of the neoadjuvant therapy, surgery is performed to remove the tumor. The surgical specimen is evaluated to determine the pathological complete response (pCR) and residual cancer burden (RCB).
Step 6
Long-term follow-up
Long-term follow-up is conducted to monitor event-free survival (EFS) and invasive disease-free survival (iDFS) over a period of up to 24 months.
Additional exploratory evaluations may include tumor tissue analysis, ctDNA assessments, and intestinal microbiome evaluation at specified intervals.

Who can join the trial?

13 criteria

Patients must be able to understand and follow instructions during the trial.
Patients need to have good kidney function, which will be checked before the trial starts. This is measured by a test called eGFR, which should be at least 30 mL/min.
Patients must be able to have an MRI or CT scan to check the tumor.
Patients should have an ECOG performance status of 2 or less. This is a scale that measures how well a patient can perform daily activities.
Patients should have a life expectancy of at least 12 months, as judged by the doctor.
Patients must be able and willing to give written consent to participate in the trial.
Both female and male patients can participate.
Patients must be at least 18 years old at the time they sign the consent form.
Patients with certain stages of triple-negative breast cancer who are candidates for specific treatments can participate. These treatments include anti-PD1 monoclonal antibody, chemotherapy with epirubicin/cyclophosphamide, and nab-paclitaxel therapy.
Patients must have a tumor that can be accessed for a biopsy and surgery.
Patients need to have good bone marrow function, which will be checked before the trial starts. This includes having enough white blood cells, platelets, and hemoglobin.
Patients should have a normal International Normalized Ratio (INR), which is a measure of blood clotting. If they are on certain blood-thinning medications, their INR should be less than 3.
Patients need to have good liver function, which will be checked before the trial starts. This includes having normal levels of bilirubin, AST, and ALT, which are substances measured in the blood to check liver health.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer other than triple negative breast cancer (TNBC). This is a specific kind of breast cancer that does not have three common receptors known to fuel most breast cancer growth.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have a medical condition that might make it unsafe for them to participate in the study.
Patients who are pregnant or breastfeeding, as the study may not be safe for them or their baby.
Patients who are currently participating in another clinical trial, as this could affect the results of the study.
Patients who have had a recent major surgery or are planning to have surgery during the study period.
Patients who have an active infection that requires treatment with antibiotics or other medications.
Patients who have a history of severe allergic reactions to any of the study medications or similar drugs.
Patients who have a condition that affects their immune system, which could interfere with the study results.

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Verified sites

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

Verified
Universitaetsklinikum Erlangen AöR
Erlangen, Germany
Verified
Universitaetsklinikum Heidelberg AöR
Heidelberg, Germany
Verified
Universitaetsklinikum Tuebingen AöR
Tuebingen, Germany

Trial locations

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Investigated drugs

NECVAX-NEO1
is an investigational therapy being studied as an additional treatment for patients with triple-negative breast cancer. It is being tested to see if it is safe and well-tolerated when used alongside another type of cancer treatment. This therapy is not yet widely available and is being evaluated in clinical trials to understand its potential benefits and any side effects.
Anti-PD-1 Monoclonal Antibody Therapy
is a type of cancer treatment that helps the immune system recognize and attack cancer cells. It works by blocking a protein called PD-1, which can prevent the immune system from effectively fighting cancer. This therapy is already used in treating various cancers and is being combined with NECVAX-NEO1 in this trial to see if the combination improves treatment outcomes for patients with triple-negative breast cancer.

What is already known about the treatment

NECVAX-NEO1 – This medication is administered as an add-on to first-line neoadjuvant anti-PD-1 monoclonal antibody therapy, specifically for patients with triple-negative breast cancer. Currently, it is being studied in a phase I/II clinical trial to evaluate its safety and tolerability. The main therapeutic indication is for use in triple-negative breast cancer, a challenging type of cancer to treat. NECVAX-NEO1 works by enhancing the immune response against cancer cells, potentially improving the effectiveness of PD-1 inhibitors. It falls under the pharmacological classification of immunotherapy agents.

Investigated diseases

Triple Negative Breast Cancer (TNBC) – 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. Because it does not have these receptors, TNBC does not respond to hormonal therapy or therapies that target HER-2 receptors. It is more common in younger women and tends to grow and spread more quickly than other types of breast cancer. TNBC is often diagnosed at a higher grade and stage, which means it may be more aggressive. The progression of TNBC can vary, but it often requires a combination of treatments to manage. Understanding the biology of TNBC is crucial for developing effective treatment strategies.