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Study on Trastuzumab and Pertuzumab for Patients with HER2-Positive Breast Cancer Using a Response-Adapted Strategy

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 a type of breast cancer known as HER2-positive breast cancer. The study is exploring a treatment approach that does not involve traditional chemotherapy. Instead, it uses two medications, trastuzumab and pertuzumab, which are designed to target and treat this specific type of cancer. These medications may be used alone or with additional hormone therapy, depending on the patient's needs.

The purpose of the study is to understand how effective this treatment is in reducing cancer in the breast and nearby lymph nodes before surgery. The study also aims to see how well patients do over a period of three years without the cancer coming back. To help guide the treatment, doctors will use a special type of scan called FDG-PET, which helps to see how the cancer is responding to the treatment early on. This scan uses a small amount of radioactive sugar to highlight areas of cancer activity in the body.

Participants in the study will receive the treatment over a period of up to 90 days. The study will monitor the effects of the treatment on the cancer and assess the overall health and quality of life of the participants. The goal is to find out if this chemotherapy-free approach can be a successful treatment option for patients with HER2-positive breast cancer.

The research process

The trial runs in 7 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 informed consent. This is a formal agreement to participate in the trial after understanding its purpose and procedures.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes checking liver and kidney function, blood cell counts, and confirming the presence of HER2-positive breast cancer.

  3. Step 3

    Treatment phase 1

    The patient will receive trastuzumab and pertuzumab intravenously. These medications are designed to target HER2-positive cancer cells.

    The treatment may include endocrine therapy, which involves taking letrozole or tamoxifen citrate orally, depending on the patient's hormone receptor status.

  4. Step 4

    FDG-PET scan

    An FDG-PET scan will be conducted to assess the metabolic response of the tumor to the treatment. This scan helps determine if the treatment is effectively reducing the cancer's activity.

  5. Step 5

    Treatment phase 2

    Based on the FDG-PET scan results, the treatment plan may be adjusted. If the tumor responds well, the patient will continue with the current treatment regimen.

    If necessary, additional medications such as docetaxel or carboplatin may be administered intravenously to enhance treatment effectiveness.

  6. Step 6

    Surgery

    After completing the treatment phases, the patient will undergo surgery to remove any remaining cancerous tissue. The success of the treatment will be evaluated by the absence of invasive disease in the breast and axilla.

  7. Step 7

    Follow-up

    The patient will be monitored for three years to assess disease-free survival. This involves regular check-ups to ensure there is no recurrence of cancer.

Who can join the trial?

13 criteria

  • The patient must provide written informed consent before starting any specific procedures related to the study.
  • The patient must have certain liver function levels: total bilirubin should be at or below the normal limit (except for a condition called Gilbert's syndrome); alkaline phosphatase (ALP) should be at or below 2.5 times the normal limit; aspartate transaminase (AST) and alanine transaminase (ALT) should be at or below 1.5 times the normal limit.
  • The patient must have certain kidney function levels: serum creatinine should be at or below 1.5 times the normal limit, or creatinine clearance should be at or above 50 mL/min/1.73 m² if creatinine levels are higher than normal.
  • The patient must be available for treatment and follow-up visits.
  • The patient must be a female or male aged 18 years or older.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, which means they are fully active or have some symptoms but do not need to stay in bed.
  • The patient must have invasive breast cancer confirmed by a tissue sample.
  • The patient must have breast cancer that can be operated on, with certain tumor sizes and locations (cT1-3 and/or cN0-2 tumors).
  • The tumor must be 1.5 centimeters or larger in diameter, as measured by MRI or ultrasound, and show significant uptake of a substance used in imaging tests.
  • If there are multiple tumors, at least two must be confirmed by tissue samples, all must be **HER2-positive**, and the largest must be 1.5 centimeters or larger.
  • The patient must have **HER2-positive** disease confirmed by specific criteria from 2018.
  • The patient must have known estrogen receptor (ER) and progesterone receptor (PR) status determined before entering the study.
  • The patient must have certain blood cell counts: white blood cell (WBC) count above 3.0 x 10⁹/L, absolute neutrophil count (ANC) at or above 1.5 x 10⁹/L, platelet count at or above 100.0 x 10⁹/L, and hemoglobin at or above 10.0 g/dL (or 6.2 mmol/L).

Who cannot join the trial?

7 criteria

  • Patients who do not have HER2-positive breast cancer cannot participate. This type of cancer has a specific protein called HER2 that promotes the growth of cancer cells.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are not willing to undergo the specific treatments being studied, such as trastuzumab and pertuzumab, cannot participate. These are medications used to treat HER2-positive breast cancer.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate, as the study treatments may affect the baby.
  • Patients who have participated in another clinical trial recently may not be eligible to participate.
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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, trastuzumab is used as part of a chemotherapy-free treatment strategy to evaluate its effectiveness in shrinking tumors and improving patient outcomes.

  • Pertuzumab

    is another medication used alongside trastuzumab for treating HER2-positive breast cancer. It also targets the HER2 protein but works in a slightly different way, complementing the action of trastuzumab. The combination of these two medications aims to enhance the treatment's effectiveness by more thoroughly blocking the signals that promote cancer cell growth.

  • Endocrine Therapy

    may be included in the treatment plan for some patients. This therapy involves using medications that block or lower the amount of hormones in the body, which can help slow or stop the growth of certain types of breast cancer that rely on hormones to grow. The use of endocrine therapy in this trial is to assess its additional benefits when combined with trastuzumab and pertuzumab.

What is already known about the treatment

  • Trastuzumab

    This medication is administered intravenously and is used in the treatment of HER2-positive breast cancer. It is well-established in medical literature as a targeted therapy for this type of cancer. Trastuzumab works by binding to the HER2 protein on cancer cells, blocking them from receiving growth signals, which helps to slow or stop the growth of the cancer. It is classified as a monoclonal antibody.

  • Pertuzumab

    This medication is also administered intravenously and is used alongside trastuzumab for treating HER2-positive breast cancer. It is recognized in medical literature as an effective treatment when combined with other therapies. Pertuzumab works by attaching to a different part of the HER2 protein than trastuzumab, preventing the cancer cells from receiving growth signals and enhancing the effect of trastuzumab. It is classified as a monoclonal antibody.

Investigated diseases

HER2-positive breast cancer – This is a type of breast cancer characterized by the overexpression of the human epidermal growth factor receptor 2 (HER2) protein, which promotes the growth of cancer cells. It tends to be more aggressive than other types of breast cancer. The disease can start in the breast tissue and may spread to nearby lymph nodes or other parts of the body. HER2-positive breast cancer can vary in size and may be detected through imaging or physical examination. The progression of the disease can be influenced by various factors, including the tumor's response to specific therapies targeting the HER2 protein.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509923-42-00Protocol codeMedOPP096 - MO39229Estimated enrolment345 patientsSponsorMedica Scientia Innovation Research S.L.

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