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Study of Ipatasertib with Trastuzumab and Pertuzumab for Patients with Advanced HER2-Positive Breast Cancer and PIK3CA Mutation

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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 treatments for patients with advanced or metastatic breast cancer that is HER2-positive and has a PIK3CA mutation. The study involves the use of several medications, including Ipatasertib, Trastuzumab (also known as Herceptin), and Pertuzumab (also known as Perjeta). Ipatasertib is an AKT inhibitor, which means it blocks a protein that can help cancer cells grow. Trastuzumab and Pertuzumab are antibodies that target the HER2 protein on cancer cells, helping to stop their growth.

The purpose of the study is to determine the best dose of Ipatasertib when used in combination with Trastuzumab and Pertuzumab. Participants will receive these medications in different forms: Ipatasertib as a tablet taken by mouth, Trastuzumab as a solution for injection or infusion, and Pertuzumab as a solution for infusion. The study will monitor how patients respond to the treatment and any side effects they may experience. The trial will also assess how long the treatment can keep the cancer from getting worse.

Throughout the study, participants will receive regular check-ups to monitor their health and the effectiveness of the treatment. The study aims to find the most effective and safe dose of Ipatasertib in combination with the other medications, which could potentially lead to better treatment options for patients with this type of breast cancer. The trial is expected to continue until December 2025.

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
Initiation of treatment
The treatment begins with the administration of ipatasertib in combination with trastuzumab and pertuzumab. This combination is used for patients with specific types of breast cancer.
The treatment must start no later than 9 weeks after the last dose of previous therapies, which include taxane or vinorelbine combined with trastuzumab and pertuzumab.
Step 2
Medication administration
Ipatasertib is taken orally in the form of film-coated tablets.
Trastuzumab is administered as a solution for injection or infusion, depending on the specific product used.
Pertuzumab is given as a solution for infusion.
Step 3
Dose determination
The primary goal is to determine the maximum tolerated dose of ipatasertib when used with trastuzumab and pertuzumab.
The recommended dose for phase 2 of the study will be established based on the results.
Step 4
Monitoring and assessment
The study will monitor the overall incidence and severity of any adverse events, with a focus on diarrhea.
The response to treatment will be evaluated using specific criteria to determine the effectiveness of the therapy.
Step 5
Duration of treatment
The study is expected to continue until December 2025, with regular assessments to monitor progress and any side effects.
The duration of response and progression-free survival will be measured to assess the long-term benefits of the treatment.

Who can join the trial?

19 criteria

Must provide written and signed consent to participate in the study.
May have received previous therapy but must have been free of disease for at least 6 months after completing anti-HER2 therapy before being diagnosed with metastatic disease.
Must have a confirmed PIK3CA mutation in tumor tissue or blood. This is a specific change in the cancer cells that can be identified through testing.
Must start treatment with the study drugs no later than 9 weeks after the last dose of previous treatment.
Must be willing to provide a sample of their tumor tissue for research purposes.
Must not have had diarrhea recently or have only mild diarrhea in the last 28 days.
Must have adequate blood and organ function, which includes specific levels of blood cells, liver enzymes, and kidney function.
Must have a life expectancy of at least 6 months.
Must have a heart function measurement of at least 50% using specific heart tests.
For women who can have children, a negative pregnancy test is required, and they must agree to use reliable birth control during the study.
Must not have any conditions that would make it difficult to follow the study procedures.
Can be either female or male.
Must be 18 years or older.
Must have a performance status of 0 or 1, which means they are fully active or have some symptoms but can carry out light work.
Must have confirmed HER2-positive breast cancer, which is a specific type of breast cancer identified by testing.
Must have known hormone receptor status, which involves testing for certain proteins in the cancer cells.
Must have a specific type of breast cancer that is either locally advanced or has spread to other parts of the body.
Must be eligible to receive maintenance therapy with specific drugs after initial treatment for metastatic disease.
Previous treatment with certain drugs must have been stopped for reasons other than the cancer getting worse.

Who cannot join the trial?

5 criteria

Patients who do not have a specific type of breast cancer called PIK3CA-mutant, HER2-positive cannot participate. This means the cancer has certain genetic changes and a specific protein on the cancer cells.
Patients who are not candidates for a treatment plan involving trastuzumab and pertuzumab after their first treatment for cancer that has spread cannot join. These are medications used to treat breast cancer.
Patients who have not received a first-line treatment with a taxane or vinorelbine along with trastuzumab and pertuzumab cannot participate. Taxane and vinorelbine are types of chemotherapy drugs.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection, cannot join the study.

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Verified sites

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Verified
Fundacion Instituto Valenciano De Oncologia
Valencia, Spain
Verified
Hospital Del Mar
Barcelona, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain

Trial locations

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Investigated drugs

Ipatasertib
is a medication being studied for its potential to treat certain types of breast cancer. It works by inhibiting a protein called AKT, which is involved in the growth and survival of cancer cells. In this trial, it is being tested to find the best dose to use in combination with other cancer treatments.
Pertuzumab
is a medication used to treat breast cancer by targeting the HER2 protein, which can promote the growth of cancer cells. It is often used in combination with other treatments to help stop the cancer from growing and spreading.
Trastuzumab
is another medication that targets the HER2 protein in breast cancer cells. It helps to slow or stop the growth of these cancer cells and is commonly used in combination with other cancer therapies to improve treatment outcomes.

What is already known about the treatment

Ipatasertib – Ipatasertib is administered orally and is currently being studied in clinical trials for its effectiveness in treating certain types of breast cancer. It is specifically being tested for patients with PIK3CA-mutant, HER2-positive locally advanced or metastatic breast cancer. The medication works by inhibiting the AKT enzyme, which plays a role in cancer cell growth and survival. Ipatasertib is classified as an AKT inhibitor and is being evaluated to determine the optimal dose when used in combination with other cancer therapies.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can be felt as a lump or seen on an X-ray. It can be classified into different types based on the presence of specific receptors, such as HER2-positive, which means the cancer cells have more HER2 protein than normal. This type of breast cancer tends to grow and spread more aggressively than other types. The progression of breast cancer can vary, with some cases remaining localized while others may spread to other parts of the body, known as metastatic breast cancer. Treatment often involves a combination of therapies, but the disease's progression depends on various factors, including the cancer's stage and specific characteristics.