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Study on Trastuzumab Emtansine, Pertuzumab, and Atezolizumab for Patients with HER2-Positive Metastatic Cancer Who Benefited from Previous Treatment

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 clinical trial is focused on studying treatments for metastatic cancer, which is a type of cancer that has spread from its original site to other parts of the body. The study involves the use of several medications, including trastuzumab emtansine, pertuzumab, and atezolizumab. Trastuzumab emtansine is being tested both as a single treatment and in combination with other anti-cancer therapies. Pertuzumab and atezolizumab are also being used in combination with trastuzumab emtansine to explore their effectiveness in treating this condition.

The purpose of the study is to provide continued treatment to patients who have previously benefited from these therapies in earlier studies. The trial aims to gather information on the safety of long-term use of trastuzumab emtansine, whether used alone or with other medications. Patients who have shown positive results from previous treatments with these drugs are given the opportunity to continue their therapy in this extension study.

Participants in the study will receive their treatment through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will monitor patients over a period to assess the safety and any side effects of the treatments. This trial is designed to ensure that patients who have responded well to these medications can continue to receive them and to collect valuable data on their long-term use.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have completed previous treatment with trastuzumab emtansine or be continuing treatment at the time of the parent study's closure.

    The patient must have received the last dose of the study drug within 6 weeks prior to the first dose in this extension study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to ensure adequate organ function. This includes checking blood counts, liver function, and kidney function.

    The patient's heart function is evaluated, requiring a left ventricular ejection fraction (LVEF) of at least 40%.

  3. Step 3

    Treatment administration

    The patient receives trastuzumab emtansine as a single agent or in combination with other medications such as pertuzumab and atezolizumab.

    All medications are administered through an intravenous infusion, which involves delivering the drug directly into the bloodstream through a vein.

  4. Step 4

    Treatment schedule

    The specific dosage and frequency of each medication are determined by the study protocol and the patient's response to treatment.

    The treatment continues as long as the patient is benefiting from it, as assessed by the study investigators.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to track the patient's response to treatment and any side effects.

    Safety data is collected to understand the long-term effects of the treatment.

  6. Step 6

    End of study participation

    The study is estimated to conclude by September 26, 2029.

    The patient may continue to receive treatment until the study ends or until it is determined that they are no longer benefiting from the treatment.

Who can join the trial?

10 criteria

  • The patient must have completed or be continuing treatment with trastuzumab emtansine (a type of cancer medication) in a previous study, or be in the control group of a specific study at the time it ended.
  • The patient must have adequate organ function, shown by specific lab results within 7 days before starting the study drug. This includes:
    • Absolute neutrophil count (a type of white blood cell) greater than 1000 cells/mm3
    • Platelet count (cells that help blood clot) greater than 75,000 cells/mm3
    • Total bilirubin (a substance made by the liver) less than or equal to 1.5 times the upper limit of normal
    • SGOT (AST) and SGPT (ALT) (liver enzymes) less than or equal to 5 times the upper limit of normal
    • Creatinine (a waste product in the blood) less than 1.8 times the upper limit of normal
    • The doctor must expect that the patient may continue to benefit from more study treatment.
    • The patient must have a Left Ventricular Ejection Fraction (LVEF) of 40% or higher, measured within 30 days before joining the study. LVEF is a measure of how well the heart pumps blood.
    • The patient must have an ECOG Performance Status of 0-2, which is a scale used to assess how a patient's disease is affecting their daily living abilities.
    • Women who can have children and men with partners who can have children must agree to use a highly effective form of non-hormonal birth control or two effective forms of non-hormonal birth control during the treatment and for a certain period after the last dose of the study drugs. Women must not donate eggs, and men must not donate sperm during this time.

Who cannot join the trial?

6 criteria

  • Patients who do not have **HER2-positive metastatic cancer**. This means the cancer must have a specific protein called HER2 that helps it grow.
  • Patients who did not benefit from previous treatment with **trastuzumab emtansine**. This is a specific medication used to treat HER2-positive cancer.
  • Patients who were not part of the **Genentech/Roche-sponsored trastuzumab emtansine parent study**. This refers to a previous study where the medication was given.
  • Patients who were not in the control group of the **BO21976/TDM4450g study** and did not benefit from the treatment given in that study.
  • Patients who are not within the specified age range for the study. The study includes certain age groups only.
  • Patients who are part of a **vulnerable population**. This means groups of people who might need special protection or care.
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Investigated drugs

Trastuzumab Emtansine is a medication used in this trial as a single agent or in combination with other anti-cancer therapies. It is designed for patients with HER2-positive metastatic cancer who have previously benefited from this treatment in earlier studies. The medication works by targeting and attacking cancer cells that have high levels of the HER2 protein, helping to slow or stop the growth of the cancer.

What is already known about the treatment

Trastuzumab Emtansine – This medication is administered intravenously, meaning it is given through a vein. It is currently used in clinical settings and is well-documented in medical literature, particularly for treating HER2-positive metastatic cancer. The main therapeutic indication is for patients with this type of cancer who have previously benefited from similar treatments. At the molecular level, trastuzumab emtansine works by combining an antibody that targets the HER2 protein on cancer cells with a chemotherapy drug, delivering the drug directly to the cancer cells and minimizing damage to normal cells. It is classified as an antibody-drug conjugate, a type of targeted cancer therapy.

Investigated diseases

Metastatic Cancer – Metastatic cancer occurs when cancer cells spread from the primary site to other parts of the body. This process involves cancer cells breaking away from the original tumor, traveling through the bloodstream or lymphatic system, and forming new tumors in other organs or tissues. The progression of metastatic cancer can vary depending on the type of primary cancer and the organs affected. Common sites for metastasis include bones, liver, lungs, and brain. Symptoms may differ based on the location of the metastases and can include pain, fatigue, and organ-specific issues. The disease is often more challenging to manage due to its widespread nature.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503479-79-00Protocol codeBO25430Estimated enrolment339 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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