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Study of Pertuzumab and Trastuzumab for Patients with Solid Malignant Tumors from Previous Pertuzumab Trials

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 focuses on patients with solid malignant tumors, which are a type of cancer that forms in solid organs or tissues. The study involves the use of a medication called pertuzumab, known by the brand name Perjeta, which is administered as a solution for infusion. Pertuzumab is used either on its own or in combination with other anti-cancer therapies. Another medication involved in the study is trastuzumab, known by the brand name Herceptin, which is also given as a solution for infusion. The purpose of the study is to continue providing pertuzumab therapy to patients who have previously participated in a related study and are still benefiting from the treatment.

Participants in this study will receive pertuzumab, and possibly trastuzumab, through an intravenous (IV) infusion, which means the medication is delivered directly into the bloodstream through a vein. The study is designed to monitor the safety and effectiveness of the treatment over time. Patients will be observed for any adverse events, which are unwanted effects that may occur during treatment. The study will also assess how long patients live without their cancer getting worse, known as progression-free survival, and overall survival, which is the length of time patients live after starting the treatment.

This study is an extension of a previous trial, meaning it continues the treatment for patients who were already receiving pertuzumab and were benefiting from it. The trial is open-label, which means both the researchers and participants know which treatment is being administered. The study aims to provide ongoing access to pertuzumab for those who need it, ensuring that patients continue to receive the potential benefits of the therapy.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after signing a written informed consent approved by the relevant ethics committee or institutional review board.

    Eligibility requires prior participation in a Roche-sponsored study involving pertuzumab and a determination by the investigator that continued treatment is beneficial.

  2. Step 2

    Treatment administration

    The study involves the administration of pertuzumab either alone or in combination with other anti-cancer therapies.

    The medication is given as an intravenous (IV) infusion. This means it is delivered directly into a vein through a needle or tube.

    The specific dosage and frequency of administration will be determined by the healthcare provider based on individual needs and previous treatment protocols.

  3. Step 3

    Monitoring and assessments

    Regular monitoring for adverse events (AEs) and serious adverse events (SAEs) is conducted. These are any unwanted effects that occur during the study.

    Progression-free survival (PFS) and overall survival (OS) are assessed to evaluate the effectiveness of the treatment. PFS refers to the length of time during and after treatment that the patient lives with the disease without it getting worse. OS refers to the length of time from the start of treatment that patients are still alive.

  4. Step 4

    Study duration

    The study is expected to continue until September 30, 2027.

    Participation will continue as long as the treatment is deemed beneficial by the healthcare provider.

Who can join the trial?

5 criteria

  • The patient must have signed a written document called an Informed Consent, which is approved by a group that ensures the study is ethical and safe.
  • The patient must have been eligible for and received a drug called pertuzumab in a previous study sponsored by Roche. This could have been given alone or with other cancer-fighting drugs.
  • The doctor must believe that the patient is still benefiting from the pertuzumab treatment.
  • Both men and women can participate in the study.
  • The study includes people who might need extra protection or care, known as a vulnerable population.

Who cannot join the trial?

2 criteria

  • Patients who have not been previously enrolled in a F. Hoffmann-La Roche (Roche)-sponsored pertuzumab study.
  • Patients who are not continuing to benefit from the pertuzumab-based therapy they received in the previous study.
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Investigated drugs

Pertuzumab is a medication used in this clinical trial. It is an anti-cancer drug that works by targeting specific proteins on the surface of cancer cells, helping to stop their growth and spread. This trial aims to continue providing this therapy to patients who have already been benefiting from it in a previous study.

What is already known about the treatment

Pertuzumab – Pertuzumab is administered intravenously, typically in combination with other anti-cancer medications. It is currently used in clinical settings and is well-documented in medical literature, particularly for its role in treating solid malignant tumors. The main therapeutic indication for pertuzumab is in the treatment of certain types of breast cancer. At the molecular level, pertuzumab works by binding to the HER2 receptor on cancer cells, blocking the receptor's ability to receive growth signals, which helps to slow or stop the growth of the cancer. It is classified as a monoclonal antibody, a type of targeted cancer therapy.

Investigated diseases

Solid Malignant Tumors – These are abnormal growths of tissue that form solid masses and can occur in various parts of the body. They are characterized by uncontrolled cell division and can invade nearby tissues. As they progress, they may spread to other parts of the body through the bloodstream or lymphatic system, a process known as metastasis. The growth rate and behavior of these tumors can vary widely depending on their location and the type of cells involved. They can cause symptoms by pressing on organs or tissues, leading to pain or dysfunction. The progression of solid malignant tumors is influenced by factors such as genetic mutations and environmental exposures.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505102-42-00Protocol codeMO29406Estimated enrolment138 patientsSponsorF. Hoffmann-La Roche AG

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