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Study of Atezolizumab and RP1 for Patients with Early-Stage Triple-Negative Breast Cancer

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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 type of breast cancer known as Triple-Negative Breast Cancer (TNBC). 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 combination of two treatments: Atezolizumab and RP1. Atezolizumab is a medication that helps the immune system fight cancer, while RP1 is a type of therapy that uses a virus to target and kill cancer cells.

The purpose of the study is to evaluate the safety and effectiveness of this combination treatment in patients with early-stage TNBC. Participants will receive the treatments before undergoing surgery to remove the cancer. The study will monitor how well the treatment works by looking at the amount of cancer left after treatment and surgery. This is known as the Residual Cancer Burden (RCB). The study will also assess any side effects experienced by participants during the treatment period.

Participants will be closely monitored throughout the study, which includes regular check-ups and tests to ensure their safety and to gather information on how the treatment is affecting the cancer. The study aims to provide valuable insights into whether this combination of treatments can improve outcomes for patients with TNBC, potentially leading to new treatment options in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial screening
Upon joining the study, a series of tests will be conducted to ensure eligibility. These tests include blood samples to check immune function and other health indicators. A pregnancy test will be required for those of childbearing potential.
A biopsy of the tumor will be performed to confirm the diagnosis of triple-negative breast cancer. Imaging tests such as mammograms, breast ultrasounds, and MRIs will be used to assess the size and location of the tumor.
Step 2
Treatment cycle 1
The first cycle of treatment involves the administration of two medications: vusolimogene oderparepvec and atezolizumab. Vusolimogene oderparepvec is given as an injection directly into the tumor, while atezolizumab is administered as an infusion into a vein.
The dosage of atezolizumab is 840 mg, and it is given as a solution for infusion. The frequency and duration of administration will be determined by the study protocol.
Step 3
Monitoring and assessment
Throughout the treatment, regular monitoring will be conducted to assess the safety and effectiveness of the medications. This includes blood tests and imaging studies to evaluate the response of the tumor to the treatment.
Additional biopsies may be performed to gather more information about the tumor and its response to the therapy.
Step 4
Subsequent treatment cycles
If the first cycle is well-tolerated, additional cycles of treatment will be administered. The number of cycles will depend on the response to the treatment and the study protocol.
The same medications, vusolimogene oderparepvec and atezolizumab, will be used in these cycles, with the same method of administration.
Step 5
Surgery
After completing the treatment cycles, surgery will be performed to remove any remaining cancerous tissue. The timing of the surgery will be based on the response to the treatment.
The goal of the surgery is to achieve a residual cancer burden of 0-1, indicating minimal or no remaining cancer.
Step 6
Post-surgery follow-up
Following surgery, regular follow-up visits will be scheduled to monitor recovery and check for any signs of cancer recurrence.
These visits will include physical examinations, imaging tests, and possibly additional blood tests to ensure ongoing health and well-being.

Who can join the trial?

22 criteria

The participant must be a female.
The participant must agree to provide blood samples at different times during the study for research purposes.
The participant must have adequate bone marrow function, which means:
- Enough white blood cells (absolute neutrophil count ≥ 1500/µL).
- Enough red blood cells (hemoglobin ≥ 9.0 g/dL).
- Enough platelets (≥ 100,000/µL).
- The participant must have adequate liver function, which means:
  - Normal levels of bilirubin (a substance made by the liver) ≤ 1.5 times the normal limit.
  - Normal levels of liver enzymes AST (SGOT) and ALT (SGPT) ≤ 3 times the normal limit.
  - The participant must have adequate kidney function, which means:
    
    Normal creatinine levels (a waste product filtered by the kidneys) ≤ 1.5 times the normal limit or a normal estimated glomerular filtration rate (eGFR ≥ 40 ml/min/1.73m²).
    The participant must have adequate blood clotting function, which means:
    
    Normal blood clotting times (INR or PT ≤ 1.5 times the normal limit and PTT or aPTT ≤ 1.5 times the normal limit).
    The participant must have a left ventricular ejection fraction (LVEF) of at least 50%, which is a measure of how well the heart pumps blood.
    If the participant is of childbearing potential, a negative pregnancy test is required within 72 hours before the first dose of the study treatment.
    Women of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 6 months after the last treatment. It is strongly recommended that their male partners also use a condom with spermicide during this time.
    The participant must sign an Informed Consent Form before any study procedures begin.
    The participant must be affiliated with the Social Security System.
    The participant must be at least 18 years old.
    The participant must have an ECOG Performance Status of 0 or 1, which is a measure of their ability to perform daily activities.
    The participant must have newly diagnosed Triple-Negative Breast Cancer (TNBC), confirmed by local testing.
    The participant's TNBC must meet specific size and spread criteria, determined by imaging tests like mammograms, ultrasounds, MRIs, and PET-CT scans.
    The cancer must be unicentric, unifocal, and unilateral, meaning it is located in one place, has one focus, and is in one breast.
    The participant must have at least 30% tumor-infiltrating lymphocytes (TILs), which are immune cells present in the tumor.
    The participant must agree to have ctDNA (circulating tumor DNA) measured at the start of the study.
    The participant must agree to provide tissue samples from biopsies and surgery for research purposes.

Who cannot join the trial?

3 criteria

Patients who do not have early-stage Triple Negative Breast Cancer.
Patients who are not female.
Patients who are considered part of a vulnerable population. This means groups of people who might need special protection or care, like children or those unable to make decisions for themselves.

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Institut Curie - Site Paris
Paris, France

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Investigated drugs

Atezolizumab
is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, Atezolizumab is being used to treat patients with a specific type of breast cancer called Triple-Negative Breast Cancer (TNBC). The goal is to see if it can help reduce the amount of cancer left in the body after surgery.
RP1
is an oncolytic immunotherapy, which means it is a type of treatment that uses a virus to infect and kill cancer cells. This therapy is designed to target and destroy cancer cells while also stimulating the immune system to attack the cancer. In this study, RP1 is being combined with Atezolizumab to see if the combination is safe and effective in treating Triple-Negative Breast Cancer before surgery.

What is already known about the treatment

Atezolizumab
Atezolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating early-stage Triple Negative Breast Cancer (TNBC). The main therapeutic indication for Atezolizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. Atezolizumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.
RP1 Oncolytic Immunotherapy
RP1 is administered through an injection directly into the tumor, allowing it to target cancer cells specifically. It is being investigated in clinical trials for its potential to treat early-stage Triple Negative Breast Cancer (TNBC) when used in combination with Atezolizumab. The main therapeutic indication for RP1 is to destroy cancer cells and stimulate an immune response against the tumor. At the molecular level, RP1 works by infecting and breaking down cancer cells, which can help the immune system recognize and attack the tumor. RP1 is classified as an oncolytic virus therapy, a form of cancer treatment that uses viruses to target and kill cancer cells.

Investigated diseases

Triple Negative Breast Cancer – Triple Negative Breast Cancer (TNBC) 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 TNBC more challenging to treat, as hormone therapies and drugs targeting HER-2 are ineffective. TNBC tends to grow and spread more quickly than other types of breast cancer. It is more likely to be diagnosed in younger women and is more common in women with a BRCA1 gene mutation. The progression of TNBC can vary, but it often involves rapid tumor growth and a higher likelihood of metastasis. Early detection and monitoring are crucial for managing the disease effectively.