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Study on the Effectiveness of Inavolisib with Trastuzumab and Pertuzumab for Patients with HER2-Positive, HR-Positive, PIK3CA Mutant Early 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 breast cancer, specifically a type known as HER2-positive, HR-positive, PIK3CA mutant early breast cancer. The study is testing a treatment that combines several medications. These include trastuzumab and pertuzumab, which are given as a solution for injection, and inavolisib, a tablet taken by mouth. The purpose of the study is to compare the effects of using these medications together with standard hormone therapy against using the hormone therapy with trastuzumab and pertuzumab alone.

Participants in the study will receive either the combination of all three medications or just the hormone therapy with trastuzumab and pertuzumab. The study will last for up to 18 months. During this time, participants will have regular check-ups and tests to monitor their response to the treatment. The goal is to see if the combination of medications can improve the rate of complete response, meaning no signs of cancer are found in the breast and nearby lymph nodes after treatment.

This study is open-label, which means both the participants and the researchers know which treatment is being given. The trial is expected to continue until March 2026. Participants will be closely monitored for any side effects or changes in their condition throughout the study period.

The research process

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

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be randomly assigned to one of two groups. One group will receive a combination of medications including trastuzumab, pertuzumab, and inavolisib, while the other group will receive trastuzumab and pertuzumab without inavolisib.

    You will be informed about the specific group you are assigned to and the treatment plan associated with it.

  2. Step 2

    Treatment administration

    If you are in the group receiving trastuzumab and pertuzumab, these medications will be administered through an injection into a vein (intravenous use).

    If you are in the group receiving inavolisib, this medication will be taken orally in the form of a tablet.

    The frequency and dosage of these medications will be determined by the study protocol and communicated to you by the medical team.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, regular monitoring and assessments will be conducted to evaluate your response to the treatment.

    These assessments may include physical examinations, imaging tests, and laboratory tests to ensure your safety and to track the effectiveness of the treatment.

  4. Step 4

    Surgery

    After completing the treatment cycles, surgery will be performed to remove any remaining tumor tissue.

    The type of surgery will depend on the response to the treatment and will be discussed with you by your healthcare provider.

  5. Step 5

    Follow-up

    Following surgery, there will be a follow-up period to monitor your recovery and any long-term effects of the treatment.

    Regular check-ups and assessments will be scheduled to ensure your continued health and well-being.

Who can join the trial?

13 criteria

  • Provide written consent to participate in the study after understanding all procedures.
  • Have a negative pregnancy test if applicable.
  • If you are a woman who can have children, agree to avoid pregnancy by not having heterosexual intercourse or using birth control methods.
  • Complete all necessary medical tests before starting the study.
  • Be willing and able to attend scheduled visits, follow treatment plans, and undergo laboratory tests and other study procedures.
  • Have a new, untreated cancer in one breast, confirmed by a specific type of biopsy called a core biopsy. Other types of biopsy are not acceptable.
  • Have a tumor in the breast that is at least 2 cm in size if it can be felt, or at least 1 cm if measured by ultrasound. The tumor must be measurable in two dimensions, preferably by ultrasound.
  • Be in certain stages of breast cancer, specifically stages cT1c to cT3. If there are multiple tumors, the largest one will be measured.
  • Have a specific type of breast cancer that is HR+/HER2+, confirmed by tests. This includes checking for ER-status, PR-status, HER2-status, PIK3CA mutation, Ki-67 value, and TILs on the biopsy. These are specific markers and mutations related to breast cancer.
  • Be at least 18 years old, and both females and males can participate.
  • Have a good general health status, specifically an ECOG Performance status of 0-1, which means you are fully active or have some symptoms but do not need bed rest.
  • Have normal heart function confirmed by an ECG and heart ultrasound within 3 months before starting the study. The heart's pumping ability, measured as LVEF, must be above 55%.
  • Meet certain laboratory test requirements for blood health, liver function, and blood sugar levels.

Who cannot join the trial?

8 criteria

  • Patients who do not have **HER2-positive** breast cancer. **HER2-positive** means the cancer has a protein that promotes the growth of cancer cells.
  • Patients who do not have **HR-positive** breast cancer. **HR-positive** means the cancer grows in response to hormones like estrogen or progesterone.
  • Patients who do not have a **PIK3CA mutation**. This is a change in a specific gene that can affect cancer growth.
  • Patients who are not receiving **endocrine therapy**. This is a treatment that blocks or removes hormones to slow or stop cancer growth.
  • Patients who are not receiving **pertuzumab** and **trastuzumab**. These are medications used to treat certain types of breast cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not female or male, as both genders are included in the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Trastuzumab is a medication used in the treatment of certain types of breast cancer. It works by targeting a specific protein called HER2, which can promote the growth of cancer cells. By attaching to the HER2 protein, trastuzumab helps to slow down or stop the growth of these cancer cells.

Pertuzumab is another medication used to treat breast cancer, often in combination with trastuzumab. Like trastuzumab, it targets the HER2 protein on cancer cells. Pertuzumab works by preventing the HER2 protein from pairing with other proteins, which can help to stop the cancer cells from growing and spreading.

Inavolisib is an experimental medication being studied for its potential to treat breast cancer. It is designed to inhibit a specific pathway in cancer cells that is often overactive in certain types of breast cancer. By blocking this pathway, inavolisib may help to reduce the growth and survival of cancer cells.

Endocrine therapy is a treatment approach used for breast cancers that are sensitive to hormones. This therapy works by blocking the body's natural hormones, like estrogen, from stimulating the growth of cancer cells. It is often used in combination with other treatments to improve outcomes for patients with hormone receptor-positive breast cancer.

What is already known about the treatment

Inavolisib – Inavolisib is administered orally in pill form and is currently being studied in clinical trials for its potential use in treating breast cancer. It is specifically being tested for patients with a type of breast cancer that is HER2-positive, HR-positive, and has a PIK3CA mutation. Inavolisib works by inhibiting a protein called PI3K, which plays a role in cancer cell growth and survival. It is classified as a PI3K inhibitor and is being evaluated for its effectiveness when used alongside other cancer treatments like endocrine therapy, pertuzumab, and trastuzumab.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It typically begins in the ducts or lobules of the breast. As the disease progresses, it can spread to nearby lymph nodes and other parts of the body. The progression of breast cancer can vary, with some forms growing slowly and others more rapidly. It is often categorized by hormone receptor status, such as HER2-positive or HR-positive, which can influence the behavior of the cancer. Early detection and monitoring are crucial for understanding the progression of the disease.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501152-28-00Protocol codeGBG 105Estimated enrolment195 patientsSponsorGBG Forschungs GmbH

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