Study of Atezolizumab, Vinorelbine, and Cyclophosphamide for Patients with Advanced Triple Negative Breast Cancer Previously Treated with Anti-PD-L1/PD-1

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What is this study about?

This clinical trial is focused on studying a specific type of advanced breast cancer known as triple negative breast cancer (TNBC). This type of cancer does not have the usual receptors that many breast cancers have, which makes it more challenging to treat. The study is testing a combination of three drugs: atezolizumab, vinorelbine, and cyclophosphamide. Atezolizumab is a medication that helps the immune system fight cancer cells. Vinorelbine is a chemotherapy drug that works by stopping cancer cells from dividing and growing. Cyclophosphamide is another chemotherapy drug that helps to kill cancer cells.

The purpose of this study is to see if this combination of drugs can activate T-cells, which are a type of immune cell, in patients with TNBC who have already been treated with medications that target proteins called PD-L1 or PD-1. These proteins can help cancer cells hide from the immune system, so targeting them can help the immune system find and attack the cancer. The study will involve patients receiving these medications through infusions, which means the drugs are given directly into the bloodstream through a vein.

Participants in the study will receive the treatment over a period of time, and researchers will monitor how well the cancer responds to the treatment. They will also look at how long the response lasts, how long patients live without the cancer getting worse, and the overall safety of the treatment combination. The study aims to provide more information on how effective this treatment is for patients with this challenging type of breast cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of triple negative breast cancer (TNBC) and previous treatment with anti-PD-L1/PD-1 regimens.

The assessment ensures that the patient has a life expectancy of at least 12 weeks and measurable disease as defined by specific criteria.

2 treatment initiation

The treatment involves a combination of three medications: atezolizumab, vinorelbine, and cyclophosphamide monohydrate.

Atezolizumab is administered as an intravenous infusion. The specific dosage and frequency are determined by the study protocol.

Vinorelbine is given orally, with the dosage and schedule specified by the study guidelines.

Cyclophosphamide monohydrate is also administered as an infusion, with weekly dosing as part of the treatment regimen.

3 ongoing monitoring

Throughout the study, regular monitoring is conducted to evaluate the treatment’s effectiveness and safety.

This includes assessments of the overall response rate, duration of response, progression-free survival, and overall survival.

Safety evaluations are performed to monitor any side effects or adverse reactions to the treatment.

4 completion of treatment

The study is estimated to conclude by December 15, 2026.

Upon completion, final assessments are conducted to determine the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

Patients must have a type of breast cancer called TNBC (Triple-Negative Breast Cancer) that cannot be removed by surgery and has spread locally or to other parts of the body.
The cancer must be confirmed by a test that shows it is negative for three specific proteins: HER2, ER, and PgR.
Patients must have at least one cancer sample that tests positive for PD-L1 using a specific test called the VENTANA PD-L1 SP142 IHC assay.
Patients should have been previously treated with medications that target PD-L1 or PD-1 in earlier stages of their treatment.
Patients must have a life expectancy of at least 12 weeks.
The disease must be measurable according to a standard called RECIST v1.1, which is a way to assess how the cancer responds to treatment.
Patients must have adequate blood and organ function, meaning their blood and organs are working well enough to handle the treatment.
Both male and female patients are eligible to participate.

Who Cannot Join the Study?

Patients who have a type of breast cancer called TNBC (Triple-Negative Breast Cancer) that cannot be removed by surgery and has spread to other parts of the body.
Patients who have already been treated with medicines that target PD-L1/PD1, which are proteins involved in the immune system’s response to cancer.
Patients who are not in the age range specified for the study.
Patients who are not eligible based on gender, as the study includes both male and female participants.
Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Azienda Sanitaria Locale Di Taranto	Taranto	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	15.06.2024

Trial locations

Investigated drugs:

Atezolizumab is a medication used in this trial to help activate the immune system. It works by blocking a protein that can stop the immune system from attacking cancer cells, allowing the body to better fight the cancer.

Vinorelbine is a chemotherapy drug used in this study to help kill cancer cells. It works by interfering with the way cancer cells divide and grow, which can slow down or stop the progression of the disease.

Cyclophosphamide is another chemotherapy medication included in the trial. It helps to destroy cancer cells by damaging their DNA, which prevents them from multiplying and spreading.

Investigated diseases:

Triple negative breast cancer

Triple-Negative Breast Cancer (TNBC) – This is a type of breast cancer that does not have the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. TNBC is considered more aggressive and difficult to treat than other types of breast cancer. It is characterized by rapid growth and a higher likelihood of spreading and recurring. The disease often presents as a lump in the breast and may be accompanied by changes in breast shape or skin texture. TNBC is more common in younger women and those with a BRCA1 gene mutation. It is typically diagnosed through imaging tests and a biopsy.

Trial ID:

2024-514031-20-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Atezolizumab, Vinorelbine, and Cyclophosphamide for Patients with Advanced Triple Negative Breast Cancer Previously Treated with Anti-PD-L1/PD-1

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?