Study on Tiragolumab, Atezolizumab, and Chemotherapy for Patients with Early and Metastatic Triple Negative Breast Cancer

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What is this study about?

This clinical trial is focused on studying treatments for triple-negative breast cancer, a type of breast cancer that does not have the three common receptors known to fuel most breast cancer growths. The study involves a combination of medications, including tiragolumab and atezolizumab, which are types of immunotherapy. Immunotherapy is a treatment that uses certain parts of a person’s immune system to fight diseases such as cancer. These medications will be used alongside chemotherapy, which is a type of cancer treatment that uses drugs to destroy cancer cells.

The purpose of the study is to determine how effective the combination of these treatments is in patients with early and metastatic triple-negative breast cancer. Metastatic cancer is cancer that has spread from the place where it first started to another place in the body. The study will be conducted in two groups: one with patients who have early-stage cancer and another with patients who have metastatic cancer. Participants will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein over a period of time.

Throughout the study, participants will be monitored to assess the response to the treatment and any side effects that may occur. The study aims to understand how well the treatment works in stopping the cancer from growing or spreading and to evaluate the overall health and quality of life of the participants. The trial will also explore the relationship between the treatment and various biological markers, which are substances in the body that can be measured to indicate a condition or disease. This information will help researchers learn more about how these treatments can be used effectively in managing triple-negative breast cancer.

1 initial visit

Upon joining the study, an initial visit is scheduled. During this visit, a detailed explanation of the trial process is provided, and any questions are addressed.

A physical examination is conducted, and blood samples are collected to ensure eligibility based on health criteria.

2 treatment plan discussion

The treatment plan is discussed, including the medications involved and their administration methods.

The medications include doxorubicin hydrochloride, paclitaxel albumin-bound, atezolizumab, carboplatin, tiragolumab, and cyclophosphamide. These are administered through intravenous (IV) infusion or injection.

3 treatment cycle

The treatment is administered in cycles. Each cycle involves receiving the medications through IV infusion or injection at specified intervals.

The frequency and dosage of each medication are determined by the study protocol and are explained in detail during the treatment plan discussion.

4 regular monitoring

Regular monitoring is conducted throughout the trial to assess health status and response to treatment.

This includes physical examinations, blood tests, and imaging studies as required by the study protocol.

5 follow-up visits

Follow-up visits are scheduled to evaluate the effectiveness of the treatment and to monitor for any side effects.

These visits include discussions with the healthcare team to address any concerns and to adjust the treatment plan if necessary.

6 end of treatment

At the end of the treatment period, a final evaluation is conducted to assess the overall response to the therapy.

This includes a comprehensive review of health status and any changes observed during the trial.

Who Can Join the Study?

Must be 18 years or older.
Must have adequate liver function. This means certain liver tests should be within normal limits.
Must have adequate kidney function. This means certain kidney tests should be within normal limits.
Must have adequate blood clotting function. This means a test called INR should be within normal limits.
Must complete all necessary screening procedures within 28 days before joining the study.
Must sign an Informed Consent form before any study-related procedures.
Must have health insurance coverage.
For Cohort A (early setting): Specific tumor and nodal stages are required, and certain types of breast tumors are allowed.
For Cohort A: Must have a heart function test result of 50% or higher.
For Cohort B (metastatic setting): No prior chemotherapy or systemic therapy for metastatic disease, except for certain genetic conditions.
Must be female.
For Cohort B: Radiation therapy for metastatic disease is allowed, and recovery from its effects is required.
For Cohort B: Prior chemotherapy is allowed if completed more than 12 months before joining the study.
For Cohort B: If there are liver metastases, certain liver tests should be within specific limits.
For Cohort B: Must have a life expectancy of at least 3 months.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have a histological diagnosis of breast cancer that is negative for estrogen, progesterone, and HER2 receptors.
Must agree to new study-related biopsies and blood sampling.
The tumor must be accessible for biopsy.
For women who can have children: Must have a negative pregnancy test within 2 weeks before the first dose of study treatment.
Women who can have children must agree to use effective contraception during the study and for 12 months after the last treatment.
Must have adequate bone marrow function. This means certain blood tests should be within normal limits.

Who Cannot Join the Study?

Patients who are not diagnosed with triple negative breast cancer cannot participate. This type of cancer does not have three common receptors known to fuel most breast cancer growth.
Only female patients can participate in this study.
Patients who are younger than 18 years old cannot participate.
Patients who are older than 65 years old cannot participate.
Patients who are part of a vulnerable population cannot participate. This means groups of people who might be at a higher risk of harm or exploitation.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Institut Curie – Site Saint-Cloud	Saint-Cloud	France
Icgtgdyh Cfefz	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	30.07.2023

Trial locations

Investigated drugs:

Tiragolumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, it is used to treat triple negative breast cancer, which is a type of breast cancer that can be more aggressive and harder to treat. Tiragolumab is combined with other treatments to see if it can improve the effectiveness of the therapy.

Atezolizumab is another immunotherapy drug used in this trial. It helps your immune system fight cancer by blocking a protein that stops the immune system from attacking cancer cells. By blocking this protein, atezolizumab can help your body’s natural defenses work better against cancer. It is used in combination with tiragolumab and chemotherapy to treat triple negative breast cancer.

Chemotherapy is a common cancer treatment that uses drugs to kill cancer cells or stop them from growing. In this trial, chemotherapy is used alongside tiragolumab and atezolizumab to see if the combination can be more effective in treating triple negative breast cancer. Chemotherapy can be given in different ways, such as through a vein or as a pill, and it targets fast-growing cancer cells in the body.

Investigated diseases:

Triple negative breast cancer

Triple Negative Breast Cancer – Triple Negative Breast Cancer (TNBC) is a type of breast cancer that lacks estrogen receptors, progesterone receptors, and excess HER2 protein. This means it does not respond to hormonal therapy or medicines that target HER2 protein receptors. TNBC is known for its aggressive nature and rapid growth. It often presents as a palpable mass in the breast and can spread to other parts of the body more quickly than other types of breast cancer. The disease is categorized into early-stage, where it is confined to the breast or nearby lymph nodes, and metastatic, where it has spread to distant organs. The progression of TNBC can vary, but it typically requires prompt and aggressive treatment due to its fast-growing nature.

Trial ID:

2022-501561-51-00

Protocol code:

IC 2022-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Tiragolumab, Atezolizumab, and Chemotherapy for Patients with Early and Metastatic Triple Negative Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?