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Study of Nadunolimab with Gemcitabine and Carboplatin for Patients with Advanced 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 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.

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Hospital Universitario De Jaen Jaen Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Hospital General Universitario De Albacete Albacete Spain
Fundacion Onkologikoa Fundazioa Donostia / San Sebastian Spain
Hospital Universitario San Juan De Alicante Sant Joan D'alacant Spain
Hospital Universitario Central De Asturias Oviedo Spain
Hospital Universitario De Toledo Ute Toledo Spain
Hospital Universitario Virgen Macarena Sevilla Spain
Hospital Universitario Clínico San Cecilio Granada Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Hospital Universitario Lucus Augusti Lugo Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
Irrlyxke Clwuiq Dodekahwmdcnblxwn L'hospitalet De Llobregat Spain
Huavoslg Ucwffydznrgxd dc A Ctlksi A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
11.01.2022

Trial locations

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.

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.

Trial ID:
2024-512052-38-00
Protocol code:
CAN04CLIN005
NCT ID:
NCT05181462
Trial Phase:
Human Pharmacology (Phase I) – Other

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