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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

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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 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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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 trial?

8 criteria

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 trial?

5 criteria

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.

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Verified sites

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

Verified
Fondazione IRCCS San Gerardo Dei Tintori
Monza, Italy
Verified
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

Trial locations

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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.

What is already known about the treatment

Atezolizumab
Atezolizumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating certain types of breast cancer. It is primarily used for patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC) who have previously been treated with anti-PD-L1/PD-1 therapies. Atezolizumab works by blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.
Vinorelbine
Vinorelbine is given intravenously and is being evaluated in combination with other drugs for its role in treating metastatic triple-negative breast cancer. It is used for patients who have not responded to previous treatments. Vinorelbine works by interfering with the growth of cancer cells, ultimately leading to their destruction. It is classified as a vinca alkaloid, which is a type of chemotherapy.
Cyclophosphamide
Cyclophosphamide is administered orally or intravenously and is part of ongoing research to assess its effectiveness in combination with other medications for breast cancer treatment. It is used for patients with advanced or metastatic triple-negative breast cancer. Cyclophosphamide works by damaging the DNA of cancer cells, preventing them from multiplying. It is classified as an alkylating agent, a type of chemotherapy.

Investigated diseases

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.