Not recruiting

Study of Nadunolimab with Gemcitabine and Carboplatin for Patients with Advanced 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 a type of breast cancer known as advanced triple negative breast cancer. This form of cancer is called "triple negative" because the cancer cells do not have three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and HER2/neu. The study is testing a new treatment combination that includes a drug called nadunolimab (also known by its code name CAN04), along with two chemotherapy drugs, gemcitabine and carboplatin. These drugs are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of this study is to evaluate how safe and effective this combination of drugs is for patients with this type of breast cancer. The study is divided into two phases. In the first phase, the focus is on assessing the safety and tolerability of the treatment, which means checking how well patients can handle the side effects. In the second phase, the study aims to see how well the treatment works in shrinking the cancer or stopping it from growing, using specific criteria to measure the response.

Participants in the study will receive the treatment over a period of time, with regular visits to the clinic for treatment administration and monitoring. The study will continue until the researchers have gathered enough information to understand the effects of the treatment. This trial is part of ongoing research to find better ways to treat advanced triple negative breast cancer and improve outcomes for patients with this challenging condition.

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
Joining the study
Upon joining the study, the patient will begin by receiving a detailed explanation of the trial procedures and requirements. This includes understanding the treatment plan, scheduled visits, and necessary laboratory tests.
The patient will provide a signed informed consent form, confirming their understanding and agreement to participate in the study.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, current health status, and any previous treatments for advanced triple negative breast cancer.
A negative serum pregnancy test is required for premenopausal women within 7 days prior to enrollment.
Step 3
Treatment initiation
The treatment involves a combination of three medications: carboplatin, gemcitabine hydrochloride, and nadunolimab (also known as CAN04).
These medications are administered through intravenous infusion, which means they are given directly into a vein.
Step 4
Phase Ib: Safety and tolerability assessment
During this phase, the focus is on assessing the safety and tolerability of the treatment combination. The main goal is to determine the maximum tolerated dose (MTD) of nadunolimab when used with gemcitabine and carboplatin.
The patient will be closely monitored for any dose-limiting toxicities during the first cycle of treatment.
Step 5
Phase II: Efficacy evaluation
In this phase, the effectiveness of the treatment is evaluated. The primary measure is the overall response rate (ORR), which includes both complete and partial responses to the treatment.
The patient's response to the treatment will be assessed using imaging techniques such as CT scans or MRIs, following specific criteria for solid tumors.
Step 6
Ongoing monitoring and follow-up
Throughout the trial, the patient will attend regular follow-up visits to monitor health status and treatment response.
Laboratory tests and imaging studies will be conducted periodically to ensure the patient's safety and to evaluate the effectiveness of the treatment.

Who can join the trial?

24 criteria

Sign an informed consent form before any study procedures begin.
If you are HIV-positive, you must meet all of these conditions:
- Have a CD4+ T-cell count of at least 350 cells per microliter (a measure of immune system health).
- No opportunistic infections (infections that occur more often or are more severe in people with weakened immune systems) in the past 12 months.
- Be on stable antiretroviral therapy (HIV treatment) for at least 4 weeks.
- Have an HIV viral load (amount of HIV in the blood) of less than 400 copies per milliliter before joining the study.
- Be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other study procedures.
- For premenopausal women, have a negative pregnancy test within 7 days before joining the study. Agree to use effective birth control methods or remain abstinent during the study and for at least 7 months after the last dose of study treatment.
- For men, agree to use birth control measures or remain abstinent during the study and for at least 6 months after the last dose of carboplatin/gemcitabine. Also, refrain from donating sperm during this period.
- Be a female or male patient aged 18 years or older.
- Have a confirmed diagnosis of **triple negative breast cancer (TNBC)** that is either locally recurrent, cannot be operated on, or has spread to other parts of the body. This includes:
  - Hormone Receptor (HR) negative breast cancer based on the most recent tumor biopsy.
  - Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer based on the most recent tumor biopsy.
  - Eligibility regardless of BRCA1/2 mutation status.
  - Be eligible to receive gemcitabine and carboplatin as the next line of therapy, with no more than one previous line of systemic therapy for advanced disease.
  - Have documented progressive disease (worsening of the disease) from the last treatment, confirmed by biopsy, pathology, or imaging report.
  - Have an **Eastern Cooperative Oncology Group (ECOG) Performance Status** of 0 or 1, which indicates the ability to carry out daily activities.
  - Have at least one measurable lesion (area of cancer) that can be accurately assessed at the start and is suitable for repeated assessment by CT scan, MRI, X-ray, or physical examination.
  - Have adequate organ and bone marrow function, defined by specific blood test results:
    
    Absolute Neutrophil Count (ANC) of at least 1,500 per cubic millimeter without recent growth factor support.
    Platelet count of at least 100,000 per cubic millimeter without recent transfusion.
    Hemoglobin level of at least 9 grams per deciliter without recent transfusion.
    Serum creatinine level within normal limits or estimated creatinine clearance of at least 60 milliliters per minute.
    Total serum bilirubin within normal limits (or higher if you have Gilbert's disease).
    AST and/or ALT levels within normal limits (or higher if liver metastases are present).
    Alkaline phosphatase levels within normal limits (or higher if bone or liver metastases are present).
    Resolution of all acute toxic effects from previous cancer treatments or surgeries to a mild level, as defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Who cannot join the trial?

5 criteria

Patients with other types of cancer that are not advanced triple negative breast cancer cannot participate. Advanced triple negative breast cancer is a specific type of breast cancer that does not have certain receptors, which are proteins that can affect cancer growth.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to safely receive the study medications, Gemcitabine and Carboplatin, cannot participate. These are chemotherapy drugs used to treat cancer.
Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate.
Patients who do not meet the specific health and safety requirements set by the study cannot participate. These requirements ensure that the study is safe for participants.

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Verified sites

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

Verified
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas De Gran Canaria, Spain
Verified
Fundacion Instituto Valenciano De Oncologia
Valencia, Spain
Responsive
Hospital Universitario De Jaen
Jaen, Spain

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Investigated drugs

Nadunolimab
is an investigational medication being studied for its potential to treat advanced triple negative breast cancer. In this trial, it is being tested to see how safe and tolerable it is when used with other cancer treatments. Researchers are also looking at how effective it is in helping to shrink tumors in patients.
Gemcitabine
is a chemotherapy drug used to treat various types of cancer, including breast cancer. It works by slowing or stopping the growth of cancer cells. In this study, it is used in combination with other treatments to see if it can improve outcomes for patients with advanced triple negative breast cancer.
Carboplatin
is another chemotherapy medication that is used to treat different cancers. It helps to kill cancer cells by damaging their DNA, which prevents them from dividing and growing. In this clinical trial, carboplatin is combined with other drugs to evaluate its effectiveness in treating advanced triple negative breast cancer.

What is already known about the treatment

Nadunolimab
Nadunolimab is administered intravenously and is currently being studied in clinical trials for its potential use in treating advanced triple negative breast cancer. It is in the investigational stage, with ongoing research to determine its safety, tolerability, and effectiveness. The main therapeutic indication is for patients with advanced triple negative breast cancer. Nadunolimab works by targeting specific proteins involved in cancer cell growth and survival, aiming to inhibit tumor progression. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.
Gemcitabine
Gemcitabine is administered intravenously and is an established chemotherapy medication used in the treatment of various cancers, including breast cancer. It is widely recognized in medical literature and is commonly used in combination with other drugs to enhance its effectiveness. The main therapeutic indication is for treating different types of cancer, including advanced triple negative breast cancer. Gemcitabine works by interfering with DNA synthesis, thereby preventing cancer cells from multiplying. It is classified as an antimetabolite, which is a type of chemotherapy drug.
Carboplatin
Carboplatin is administered intravenously and is a well-known chemotherapy drug used to treat various cancers, including breast cancer. It is well-documented in medical literature and is often used in combination with other chemotherapy agents. The main therapeutic indication is for treating different types of cancer, including advanced triple negative breast cancer. Carboplatin works by binding to DNA and causing cross-linking, which prevents cancer cells from dividing and growing. It is classified as a platinum-based chemotherapy drug.

Investigated diseases

Advanced 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. Because it does not have these receptors, it does not respond to hormonal therapy or medicines that target HER-2. It is considered more aggressive than other types of breast cancer. The disease often progresses quickly and can spread to other parts of the body. It is more likely to recur after treatment compared to other breast cancer types. This form of cancer is more common in younger women and those with a BRCA1 gene mutation.