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Study on the Effectiveness and Safety of Tocilizumab and Drug Combination for Patients with Metastatic 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 different treatment combinations for patients with metastatic breast cancer. This includes various subtypes such as triple negative breast cancer (TNBC), hormone receptor positive breast cancer (HR+ BC), and HER2 positive and HER2 low breast cancer (HER2+/HER2-low BC). The study aims to evaluate the effectiveness and safety of these treatments. The medications being tested include ACTEMRA (tocilizumab), Kisqali (ribociclib), inavolisib (also known as GDC-0077), Tecentriq (atezolizumab), Abraxane (paclitaxel albumin-bound), Verzenios (abemaciclib), and Faslodex (fulvestrant). Some patients may receive a placebo as part of the study.

The purpose of the study is to assess how well these treatment combinations work and how safe they are for patients. Participants will receive one or more of these medications, and their health will be monitored closely throughout the study. The study will look at how the cancer responds to the treatments and any side effects that may occur. This will help researchers understand which combinations are most effective and safe for treating metastatic breast cancer.

The study is designed to be conducted in stages, with each stage focusing on different aspects of treatment response and safety. Participants will undergo regular health assessments, including checks on vital signs and laboratory tests, to track any changes from the start of the study. The study is expected to continue until 2026, providing valuable information on the potential benefits and risks of these treatment combinations for patients with metastatic breast cancer.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure adequate health status.

  2. Step 2

    Treatment phase 1

    The first stage of treatment involves receiving a combination of medications. The specific combination depends on the type of breast cancer diagnosed.

    Medications may include ACTEMRA administered through an intravenous infusion, Kisqali tablets taken orally, and inavolisib tablets taken orally.

    Other medications such as Tecentriq and Abraxane are also administered through intravenous infusions.

  3. Step 3

    Monitoring and evaluation

    Throughout the treatment, regular monitoring is conducted to evaluate the effectiveness and safety of the medication combinations.

    This includes tracking the objective response rate, which measures how well the cancer responds to treatment, and monitoring for any adverse effects.

  4. Step 4

    Treatment phase 2

    In the second stage, adjustments to the treatment plan may be made based on the initial response and any side effects experienced.

    Additional medications such as Faslodex injections and Verzenios tablets may be introduced.

  5. Step 5

    Final assessment

    At the end of the treatment period, a comprehensive assessment is conducted to determine the overall effectiveness of the treatment.

    This includes evaluating changes in vital signs, laboratory test results, and any remaining cancer activity.

Who can join the trial?

6 criteria

  • Must be 18 years or older at the time of signing the consent form.
  • Must have an ECOG Performance Status of 0 or 1. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, and 1 means some restrictions but still able to do light work.
  • Must have metastatic or inoperable locally advanced breast cancer. This means the cancer has spread to other parts of the body or cannot be removed by surgery.
  • Must have measurable disease according to RECIST v1.1. This means there is at least one tumor that can be measured in size using specific guidelines.
  • Must have a life expectancy of at least 3 months, as determined by the doctor.
  • Must have adequate hematologic and end-organ function. This means the blood and organs are working well enough, as shown by specific lab test results taken within 14 days before starting the study treatment.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer that are not specified in the study.
  • Patients who have not fully recovered from previous cancer treatments.
  • Patients with serious heart problems.
  • Patients with uncontrolled infections.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of severe allergic reactions to similar treatments.
  • Patients with certain medical conditions that could interfere with the study.
  • Patients who are unable to follow the study procedures.
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Investigated drugs

  • Trastuzumab

    is a medication used in the treatment of certain types of breast cancer. It works by targeting and blocking the function of a protein called HER2, which can promote the growth of cancer cells. By inhibiting this protein, trastuzumab helps to slow down or stop the growth of cancer.

  • Paclitaxel

    is a chemotherapy drug that is used to treat various types of cancer, including breast cancer. It works by interfering with the normal function of microtubules during cell division, which prevents cancer cells from dividing and growing.

  • Ribociclib

    is a medication used in combination with other drugs to treat breast cancer. It works by inhibiting certain proteins known as CDK4 and CDK6, which are involved in cell division. By blocking these proteins, ribociclib helps to slow down the growth of cancer cells.

  • Letrozole

    is a medication used to treat breast cancer in postmenopausal women. It works by reducing the amount of estrogen produced in the body, which can help slow or stop the growth of certain types of breast cancer cells that need estrogen to grow.

  • GDC-9545

    is an investigational drug being studied for its potential use in treating breast cancer. It is designed to target and block the activity of estrogen receptors, which can help prevent the growth of cancer cells that rely on estrogen.

What is already known about the treatment

  • Tiragolumab

    Tiragolumab is a medicine given as an infusion into the bloodstream that is currently being studied in clinical trials for the treatment of metastatic breast cancer, including triple-negative breast cancer, hormone receptor-positive breast cancer, and HER2-positive as well as HER2-low breast cancer. It is an antibody that works by blocking a protein called TIGIT on immune system cells, which helps the body's own immune system better recognize and attack cancer cells. The medicine belongs to the immunotherapy group and is often tested in combination with other cancer medicines to improve treatment results.

  • Atezolizumab

    Atezolizumab is an approved immunotherapy medicine given as an infusion directly into the bloodstream and used to treat several types of cancer, including metastatic breast cancer. It works by blocking a protein called PD-L1 on the surface of cancer cells, which allows the body's immune system to detect and fight the cancer cells more effectively. The medicine belongs to the group of checkpoint inhibitors and has proven particularly effective when combined with other cancer treatments.

  • Paclitaxel

    Paclitaxel is an established chemotherapy medicine given as an infusion into the bloodstream and used to treat various types of cancer, including breast cancer. It works by interfering with the ability of cancer cells to divide by affecting their internal skeletal structure, which causes the cancer cells to stop growing and eventually die. The medicine belongs to the taxane group and is one of the most common chemotherapy treatments for breast cancer.

Investigated diseases

Metastatic Breast Cancer – This is a type of breast cancer that has spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. It can include various subtypes like triple-negative breast cancer, hormone receptor-positive breast cancer, and HER2-positive or HER2-low breast cancer. The disease progresses as cancer cells travel through the bloodstream or lymphatic system to form new tumors in other organs. Symptoms can vary depending on where the cancer has spread, but may include bone pain, changes in skin texture, or difficulty breathing. The progression can be influenced by the cancer's subtype and the body's response to the disease.
Trial detailsLast updated 27 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503629-20-00Protocol codeCO40115Estimated enrolment325 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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