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Study of ipatasertib with atezolizumab and chemotherapy in women with triple-negative breast cancer before surgery

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with triple-negative breast cancer. The research evaluates a combination treatment approach using three different therapies: standard chemotherapy, atezolizumab (given through intravenous infusion), and ipatasertib (taken as tablets by mouth). Triple-negative breast cancer is a type of breast cancer where the tumor cells lack three common receptors that are often used as targets for breast cancer treatment.

The main purpose is to determine whether adding ipatasertib to the combination of chemotherapy and atezolizumab improves treatment outcomes in patients with or without specific genetic changes in their tumors, specifically alterations in PIK3CA, AKT1, or PTEN genes. The study will also examine how the addition of ipatasertib affects the body's immune response to the cancer.

During the study, patients will receive either the combination of standard chemotherapy with atezolizumab, or the same treatment plus ipatasertib. The treatment will be given before surgery (this is called neoadjuvant treatment) to try to shrink the tumor. The maximum daily dose of atezolizumab will be 840 mg, while ipatasertib will be given at a maximum daily dose of 400 mg. The effectiveness of the treatment will be evaluated by examining the breast tissue removed during surgery to check if any cancer cells remain.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive a combination of treatments including chemotherapy, atezolizumab (Tecentriq), and possibly ipatasertib, depending on your assigned treatment group.
Atezolizumab will be given through an intravenous infusion (directly into your vein).
If prescribed, ipatasertib will be given as film-coated tablets that you take by mouth.
Step 2
Monitoring and assessment
Your doctor will regularly check your health status and perform tests to monitor how your body responds to the treatment.
The medical team will measure the size of your tumor using imaging tests to assess your response to treatment.
Blood tests will be performed to check your blood cell counts and organ function.
Step 3
Quality of life assessment
You will be asked to complete questionnaires about your symptoms and how you feel during the treatment.
These assessments help track changes in your daily functioning and treatment-related symptoms.
Step 4
Surgery phase
After the initial treatment phase, surgery will be performed to remove any remaining tumor tissue.
Tissue samples from your breast and lymph nodes will be examined to determine your response to the treatment.
Step 5
Follow-up period
After completing treatment, regular follow-up visits will be scheduled to monitor your health.
The medical team will check for any signs of cancer return and manage any lasting side effects.
This monitoring will continue until the study ends in June 2025.

Who can join the trial?

9 criteria

Must be female and at least 18 years old
Must be able and willing to provide written informed consent
Must have good physical functioning status (ECOG score 0-1, meaning able to carry out light daily activities)
Must have confirmed triple-negative breast cancer through specific laboratory tests
Must have either: - Cancer that has spread to lymph nodes, or - Tumor size of at least 2 centimeters
Must have adequate blood test results showing: - Sufficient white blood cells - Sufficient platelets - Sufficient hemoglobin (oxygen-carrying blood component) - Normal liver function - Normal kidney function
If able to become pregnant, must: - Have a negative pregnancy test - Agree to use effective birth control during treatment and for 12 months after
Must be able to follow study protocol requirements
Must have breast tumor tissue samples available for testing, either from previous biopsies or be willing to undergo a biopsy

Who cannot join the trial?

15 criteria

Previous treatment with immunotherapy or atezolizumab (a type of cancer immunotherapy drug)
Known allergy or sensitivity to study medications or their components
Prior treatment with AKT inhibitors (a type of targeted cancer therapy)
Male patients (study is for female patients only)
Age below 18 or above 65 years
Active or untreated brain metastases (cancer that has spread to the brain)
Significant heart conditions or cardiovascular disease
Active autoimmune diseases (conditions where the immune system attacks healthy cells)
Current or recent use of systemic corticosteroids (medications that reduce inflammation)
Other active cancers requiring treatment
Pregnancy or breastfeeding
Serious infections, including active tuberculosis or hepatitis B/C
Inadequate organ function (liver, kidneys, bone marrow)
History of HIV infection
Psychiatric conditions that could interfere with study participation

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Verified sites

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

Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital Clinico San Carlos
Verified
Madrid, Spain

Trial locations

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Investigated drugs

Atezolizumab is a medication that helps the immune system fight cancer cells. It works by blocking a protein that cancer cells use to hide from the immune system, allowing the body's natural defenses to better recognize and attack the cancer. Ipatasertib is a medication that targets and blocks a specific protein called AKT, which can help control cancer cell growth. It is being studied in combination with other treatments to see if it can improve the effectiveness of cancer therapy. Neoadjuvant chemotherapy (NACT) refers to standard chemotherapy medications given before surgery to help shrink tumors and make them easier to remove. This approach can also help doctors see how well the cancer responds to treatment.

What is already known about the treatment

Atezolizumab
An immunotherapy medication administered through intravenous infusion that belongs to the class of immune checkpoint inhibitors. It works by blocking the PD-L1 protein, helping the immune system recognize and attack cancer cells, particularly in the treatment of triple-negative breast cancer. This medication is currently approved and widely used in clinical practice, showing significant effectiveness in combination with chemotherapy for breast cancer treatment.
Ipatasertib
An oral medication that functions as an AKT inhibitor, targeting a specific cellular pathway involved in cancer cell growth and survival. It is currently being investigated in clinical trials for triple-negative breast cancer treatment, particularly in combination with chemotherapy and immunotherapy. The medication works by blocking the AKT protein, which plays a crucial role in cancer cell proliferation and survival mechanisms.

Investigated diseases

Triple-negative breast cancer - A type of breast cancer where cancer cells lack three common receptors: estrogen, progesterone, and HER2 protein. This cancer typically grows and spreads more quickly than other types of breast cancer. It is characterized by the presence of abnormal cells that develop in the breast tissue, forming tumors that can be detected through imaging or physical examination. The condition tends to be more common in younger women and those with specific genetic mutations. The disease can spread from the breast to nearby lymph nodes and potentially to other parts of the body.