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Study on Chemotherapy-Free Treatment with Trastuzumab, Pertuzumab, and T-DM1 for Patients with HER2-Positive Early-Stage 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 a type of breast cancer known as HER2-positive early-stage breast cancer. This type of cancer is characterized by the overexpression of a protein called HER2, which can promote the growth of cancer cells. The study is exploring a treatment approach that does not involve traditional chemotherapy. Instead, it uses a combination of medications, including Phesgo, which contains the active substances trastuzumab and pertuzumab, and another medication called trastuzumab emtansine (also known as T-DM1). These medications are designed to target and block the HER2 protein, potentially slowing or stopping the growth of cancer cells.

The purpose of the study is to evaluate the effectiveness and safety of this treatment approach in patients who have not received prior treatment for their HER2-positive breast cancer. Participants in the study will receive the medications through injections, with Phesgo being administered under the skin (subcutaneous use) and trastuzumab emtansine being given through a vein (intravenous use). The study will monitor patients over a period of time to assess how well the treatment works in preventing the cancer from returning and to evaluate any potential side effects on the patients' overall health.

Throughout the study, participants will undergo regular health assessments, including imaging tests like MRI to track the response of the cancer to the treatment. The study aims to provide insights into whether this chemotherapy-free approach can effectively manage HER2-positive early-stage breast cancer while maintaining the patients' quality of life. The trial will also look at the long-term outcomes, such as the recurrence of cancer and overall survival rates, to determine the potential benefits of this treatment strategy.

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 will provide written consent to participate.

    The patient will undergo initial assessments to confirm eligibility, including tests for heart function, blood health, and organ function.

  2. Step 2

    Initial treatment phase

    The patient will receive a combination of medications: trastuzumab and pertuzumab.

    These medications are administered as a subcutaneous injection, which means they are injected under the skin.

    The dosage will be either 600 mg/600 mg or 1200 mg/600 mg, depending on the specific treatment plan.

  3. Step 3

    Monitoring and assessment

    The patient's response to the treatment will be monitored regularly through medical imaging and other tests.

    Blood samples will be collected at various points, including before treatment, before surgery, and at regular intervals after surgery.

  4. Step 4

    Surgery

    If necessary, surgery will be performed to remove any remaining cancerous tissue.

    Tumor tissue samples will be collected during surgery for further analysis.

  5. Step 5

    Post-surgery treatment

    After surgery, the patient may receive additional treatment with trastuzumab emtansine, administered intravenously.

    The frequency and duration of this treatment will be determined based on the patient's specific needs and response to previous treatments.

  6. Step 6

    Long-term follow-up

    The patient will continue to be monitored for several years to assess the long-term effectiveness and safety of the treatment.

    Regular follow-up visits will include health assessments and possibly additional imaging or tests.

Who can join the trial?

16 criteria

  • Must provide written consent before starting any study procedures.
  • Normal heart function, with a left ventricular ejection fraction (LVEF) of at least 55%, checked by a heart ultrasound or a special heart scan within 28 days before the first treatment dose.
  • Good bone marrow, liver, and kidney function, with specific blood test results within normal limits.
  • Must be available for treatment and follow-up visits.
  • Willing and able to provide blood samples at specific times before and after surgery, and regularly for the first 5 years, then yearly.
  • Willing and able to provide tumor tissue samples before and during surgery.
  • Women who can have children and men with partners who can have children must use effective nonhormonal birth control during the study and for seven months after the last treatment dose.
  • Negative pregnancy test for women who can have children, including those who have had a tubal ligation or are less than 12 months into menopause.
  • Must be 18 years of age or older.
  • Must have a performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must have a confirmed invasive breast cancer diagnosis.
  • Tumor size must be between 5mm and 25mm, as measured by ultrasound and mammography, or between 5mm and 30mm by MRI.
  • Must have node-negative breast cancer, meaning no cancer in the lymph nodes, confirmed by clinical exam, MRI, and ultrasound.
  • Must have a confirmed HER2-positive status with an IHC score of 3+.
  • Must know estrogen receptor (ER) and progesterone receptor (PgR) status before starting the study, tested by local standards.
  • Patients with multiple breast cancer areas are eligible if they have two or fewer lesions, and both meet specific criteria.

Who cannot join the trial?

7 criteria

  • Patients who have already received treatment for their breast cancer.
  • Patients whose breast cancer is not confirmed as HER2-Positive. HER2-Positive means the cancer cells have more HER2 protein than normal, which can make the cancer grow faster.
  • Patients with breast cancer that is not in the early stage. Early-stage means the cancer is still small and hasn't spread much.
  • Patients with breast cancer that has spread to the lymph nodes. Lymph nodes are small glands that help fight infection.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not considered part of the vulnerable population selected for the study.
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Investigated drugs

  • Trastuzumab

    is a medication used in the treatment of HER2-positive breast cancer. It works by targeting the HER2 protein on the surface of cancer cells, helping to stop their growth and spread. In this trial, it is administered as a subcutaneous injection, which means it is given under the skin.

  • Pertuzumab

    is another medication used to treat HER2-positive breast cancer. It works in a similar way to trastuzumab by targeting the HER2 protein, but it binds to a different part of the protein. This helps to enhance the effect of trastuzumab and further inhibit cancer cell growth. It is also given as a subcutaneous injection in this trial.

  • T-DM1

    , also known as ado-trastuzumab emtansine, is a combination of trastuzumab and a chemotherapy drug. It is designed to deliver the chemotherapy directly to the cancer cells by attaching it to trastuzumab, which targets the HER2 protein. This helps to kill the cancer cells while minimizing damage to healthy cells.

What is already known about the treatment

  • Trastuzumab

    This medication is administered subcutaneously and is currently being studied in clinical trials for its effectiveness in treating early-stage HER2-positive breast cancer. It is widely recognized in medical literature as a targeted therapy for breast cancer. The main therapeutic indication is for patients with previously untreated HER2-positive early-stage breast cancer. At the molecular level, trastuzumab works by binding to the HER2 receptor on cancer cells, inhibiting their growth and survival. It is classified as a monoclonal antibody.

  • Pertuzumab

    Administered subcutaneously, pertuzumab is being evaluated in clinical trials for its role in treating early-stage HER2-positive breast cancer. It is well-documented in medical literature as a targeted therapy used in combination with other medications. The primary therapeutic indication is for patients with previously untreated HER2-positive early-stage breast cancer. Pertuzumab works by binding to a different part of the HER2 receptor than trastuzumab, preventing the receptor from pairing with other HER receptors, which inhibits cancer cell growth. It is classified as a monoclonal antibody.

  • T-DM1

    This medication is administered intravenously and is under investigation in clinical trials for its use in early-stage HER2-positive breast cancer. It is recognized in medical literature as an antibody-drug conjugate. The main therapeutic indication is for patients with previously untreated HER2-positive early-stage breast cancer. T-DM1 combines trastuzumab with a chemotherapy drug, delivering the chemotherapy directly to the cancer cells by binding to the HER2 receptor, which helps to kill the cancer cells while minimizing damage to normal cells. It is classified as an antibody-drug conjugate.

Investigated diseases

HER2-Positive Early-Stage Breast Cancer – This is a type of breast cancer characterized by the overexpression of the HER2 protein, which promotes the growth of cancer cells. It is considered early-stage when the cancer is confined to the breast or nearby lymph nodes and has not spread to distant parts of the body. The disease progresses as the cancer cells grow and potentially spread to nearby tissues. HER2-positive breast cancer tends to grow and spread more aggressively than other types of breast cancer. The progression can vary, with some cases remaining localized while others may advance more rapidly. Understanding the specific characteristics of the tumor, such as hormone receptor status and tumor size, is crucial in determining the course of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508738-32-00Protocol codeMEDOPP293Estimated enrolment396 patientsSponsorMedica Scientia Innovation Research S.L.

sourced from the EU Clinical Trials Register and site verification

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