Study on Immunotherapy with Atezolizumab, Tiragolumab, and Ipilimumab for Patients with Advanced Triple Negative Breast Cancer

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What is this study about?

This clinical trial is focused on studying new treatment strategies for patients with advanced Triple Negative Breast Cancer (TNBC). TNBC is a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER2 protein. This study will explore the effectiveness and safety of novel immunotherapy treatments for patients with advanced stages of this disease, which may include cases where the cancer has spread to other parts of the body or cannot be surgically removed.

The trial will involve the use of several medications, including Tecentriq (atezolizumab), Tiragolumab, and YERVOY (ipilimumab). These medications are given as a solution through an intravenous infusion, which means they are administered directly into the bloodstream through a vein. The study will also include a placebo group to help compare the effects of the treatments. The main goal is to determine how well these treatments work and how safe they are for patients with advanced TNBC.

Participants in the study will receive treatment over a period of up to 24 months. During this time, they will be monitored for any changes in their condition and any side effects they may experience. The study aims to see if these new treatments can help control the cancer and improve the quality of life for patients with advanced TNBC. The trial will also assess how long patients can live without the disease getting worse and overall survival rates. This research is part of ongoing efforts to find better treatment options for people with this challenging form of breast cancer.

1 initial visit and consent

Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to sign an informed consent form, which confirms your understanding and agreement to participate in the trial.

2 baseline assessments

Before starting treatment, several assessments will be conducted to establish your baseline health status. These may include blood tests, imaging scans, and a biopsy of a metastatic lesion if accessible.

3 treatment initiation

You will begin receiving the study medications through intravenous infusion. The medications include atezolizumab, tiragolumab, and ipilimumab. The specific dosage and frequency will be determined by the study protocol and your healthcare team.

4 ongoing treatment and monitoring

Throughout the trial, you will continue to receive the study medications as per the schedule. Regular monitoring will be conducted to assess your response to the treatment and to check for any side effects. This may involve additional blood tests, imaging scans, and possibly more biopsies.

5 12-week evaluation

After 12 weeks of treatment, a comprehensive evaluation will be performed to determine the progression-free survival rate. This involves assessing whether the cancer has progressed or if there have been any adverse events.

6 follow-up and final assessments

At the end of the treatment period or if you decide to leave the study, final assessments will be conducted. These will help determine the overall survival and clinical benefit of the treatment.

Who Can Join the Study?

Must have advanced triple negative breast cancer (TNBC), which means the cancer has spread or cannot be removed by surgery.
Must have a confirmed diagnosis showing estrogen receptor (ER) and HER2 negativity on a biopsy of the cancer that has spread.
Must have certain blood test results within specific limits, such as:
- Bilirubin less than 1.5 times the normal limit (except for those with Gilbert Syndrome, where it can be less than 3 times the normal limit).
- Alkaline phosphatase less than 2.5 times the normal limit (or less than 5 times if cancer has spread to the liver, and less than 7 times if it has spread to the bones).
- Transaminases (ASAT/ALAT) less than 3 times the normal limit (or less than 5 times if cancer has spread to the liver).
- LDH less than 2 times the normal limit.
Must have a creatinine clearance (a measure of kidney function) greater than 40 mL/min.
Must have signed an informed consent, which means agreeing to participate after understanding the study details.
Must have PD-L1 negative disease or have been previously treated with anti-PD(L)1 therapy.
Must have a cancer lesion that can be biopsied (sampled) for study purposes.
Must be 18 years or older.
Must have a WHO performance status of 0 or 1, indicating good physical health.
Must have had a maximum of three lines of chemotherapy for cancer that has spread, with evidence of disease progression.
Must have measurable or evaluable disease according to specific criteria (RECIST 1.1).
Must have a disease-free interval longer than 1 year, unless the cancer was metastatic from the start or no prior chemotherapy was given.
Must have certain blood cell counts within specific limits, such as:
- White blood cells (WBC) at least 2.0 x 10⁹/L.
- Absolute neutrophil count (ANC) at least 1.5 x 10⁹/L without recent use of growth factors.
- Platelets at least 100 x 10⁹/L.
- Hemoglobin at least 5.0 mmol/L.

Who Cannot Join the Study?

Patients with advanced TNBC (Triple-Negative Breast Cancer) that cannot be surgically removed or has spread to other parts of the body cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Netherlands Cancer Institute	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.02.2024

Trial locations

Investigated drugs:

Immunotherapy is a type of treatment that helps your body’s immune system fight cancer. In this trial, the focus is on using new strategies to boost the immune system’s ability to target and destroy cancer cells in patients with advanced triple-negative breast cancer. This approach aims to enhance the body’s natural defenses to improve the effectiveness of cancer treatment.

Triple-Negative Breast Cancer (TNBC) – Triple-Negative Breast Cancer 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. This absence makes it more challenging to treat, as hormone therapies and drugs targeting HER-2 are ineffective. TNBC tends to be more aggressive and has a higher likelihood of spreading and recurring compared to other breast cancer types. It often progresses rapidly, with symptoms including a lump or mass in the breast, changes in breast shape, and skin dimpling. The disease can advance to an irresectable recurrent stage, where the cancer returns and cannot be surgically removed, or to a metastatic stage, where it spreads to other parts of the body. Monitoring and managing the disease focus on slowing progression and managing symptoms.

Trial ID:

2023-507875-23-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Immunotherapy with Atezolizumab, Tiragolumab, and Ipilimumab for Patients with Advanced Triple Negative Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?