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Study on Time Savings with Subcutaneous Pertuzumab and Trastuzumab for Patients with HER2-Positive Early Breast Cancer

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

The study looks at patients with HER2-positive early breast cancer, a type of breast cancer that has a protein called HER2 on the surface of the cancer cells. The treatment being examined is a fixed‑dose combination of two medicines, pertuzumab and trastuzumab, given as a single subcutaneous injection (under the skin). This combination is referred to as PH FDC SC. For comparison, the study also looks at the usual way of giving the same medicines separately by infusion (slow drip into a vein) or by injection.

The main aim of the study is to measure how much time health‑care professionals and patients may save when the combined subcutaneous injection is used instead of the separate infusion or injection methods. Participants will receive the assigned treatment for several cycles over several months, with each cycle involving a visit to the treatment center where the medication is given, followed by routine check‑ups. Throughout the study, safety and how well patients tolerate the medicines will be monitored.

Safety checks include recording any side effects, especially heart‑related effects, and performing basic lab tests and heart function assessments. The study follows patients through the treatment period, recording the time spent in the treatment chair, the time in the treatment room, and the overall time spent in the hospital for each visit. Data on the amount of medication used and any waste are also collected.

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, participants will be required to sign an informed consent form. This document confirms understanding and agreement to participate in the clinical trial.

  2. Step 2

    Initial health assessment

    Participants will undergo a baseline health assessment. This includes an echocardiogram or a multiple-gated acquisition scan to ensure the heart's left ventricular ejection fraction is at least 55%.

    A negative serum pregnancy test is required for women of childbearing potential before starting the trial.

  3. Step 3

    Treatment administration

    Participants will receive a combination of medications for the treatment of HER2-positive early breast cancer. The medications include trastuzumab and pertuzumab.

    The treatment involves different administration methods: Phesgo is given as a subcutaneous injection, while Perjeta and Herceptin are administered intravenously.

    The specific dosages are: Phesgo 1200 mg/600 mg or 600 mg/600 mg for injection, Perjeta 420 mg for infusion, and Herceptin 600 mg for injection or 150 mg for infusion.

  4. Step 4

    Treatment cycles

    The treatment is administered in cycles, specifically from cycle 2 to cycle 7 in the adjuvant setting. Each cycle involves a visit where the medication is administered.

    During each visit, the time spent in the treatment room and the time sitting in the infusion chair will be measured.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, participants will be monitored for any side effects or adverse events. This includes regular checks of vital signs and laboratory tests.

    Participants are required to follow specific guidelines regarding contraception and abstinence to prevent pregnancy during the trial and for seven months after the last dose of the medication.

  6. Step 6

    Completion of the trial

    The trial is expected to end by April 5, 2025. Upon completion, participants may undergo a final health assessment to evaluate the overall impact of the treatment.

Who can join the trial?

14 criteria

  • Signed Informed Consent Form.
  • Heart function test result showing a Left Ventricular Ejection Fraction (LVEF) of 55% or higher. This is a measure of how well your heart is pumping.
  • For women who can have children and are sexually active: Agree to either not have heterosexual intercourse or use one highly effective nonhormonal birth control method, or two effective nonhormonal methods during the study and for 7 months after the last dose of HER2-targeted therapy. Also, agree not to donate eggs during this time.
  • For men: Agree to either not have heterosexual intercourse or use a condom with a spermicidal product during the study and for 7 months after the last dose of HER2-targeted therapy. Also, agree not to donate sperm during this time.
  • A negative pregnancy test for women who can have children, unless they have had surgery to remove ovaries or uterus.
  • No major surgery unrelated to breast cancer within 28 days before starting the study, and no plans for major surgery during the study.
  • Must be 18 years or older at the time of signing the Informed Consent Form.
  • Ability to follow the study rules, as judged by the study doctor.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which means you are fully active or have some symptoms but can carry out light work.
  • Must have locally advanced, inflammatory, or early-stage breast cancer that is in one breast and confirmed by a lab test. The cancer must be node-positive, meaning it has spread to nearby lymph nodes, but not to other parts of the body.
  • Completed initial treatment with pertuzumab and trastuzumab along with chemotherapy, and have had surgery for breast cancer. Study treatment must start between 2 to 8 weeks after surgery.
  • Confirmed total pathologic complete response (tpCR), meaning no invasive cancer is found in the breast and lymph nodes after treatment, as assessed by a local pathologist.
  • HER2-positive breast cancer confirmed by a local lab before joining the study. HER2-positive means the cancer has high levels of a protein that promotes cancer growth.
  • Hormone receptor status of the primary tumor must be determined by a local lab. It can be either positive (estrogen receptor-positive and/or progesterone receptor-positive) or negative (estrogen receptor-negative and progesterone receptor-negative).

Who cannot join the trial?

4 criteria

  • Patients who do not have HER2-positive early breast cancer cannot participate. This means the cancer must have a specific protein called HER2.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important to check if you fit the required age group.
  • Both female and male patients can participate, so gender is not a reason for exclusion.
  • Patients who are considered part of a vulnerable population may not be eligible. This can include groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

  • Pertuzumab

    is a medication used in the treatment of HER2-positive breast cancer. It works by targeting a specific protein on the surface of cancer cells, which helps to slow down or stop the growth of the cancer. In this clinical trial, pertuzumab is being studied in combination with another medication to see if it can save time for both healthcare providers and patients when given as a subcutaneous injection, which is an injection under the skin.

  • Trastuzumab

    is another medication used to treat HER2-positive breast cancer. Like pertuzumab, it targets the HER2 protein on cancer cells, helping to prevent the cancer from growing and spreading. In this trial, trastuzumab is being combined with pertuzumab in a fixed-dose combination that is administered as a subcutaneous injection. The study aims to determine if this method of administration can save time compared to the traditional intravenous method, where the medication is given directly into a vein.

What is already known about the treatment

Pertuzumab and Trastuzumab Fixed-Dose Combination – This medication is administered as a subcutaneous injection, which means it is given under the skin. It is currently being studied for its effectiveness in treating HER2-positive early breast cancer, a type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). The main therapeutic use of this combination is to target and block the HER2 protein, which can promote the growth of cancer cells. By doing so, it helps to slow down or stop the growth of these cancer cells. Pertuzumab and trastuzumab belong to a class of drugs known as monoclonal antibodies, which are designed to specifically target and bind to certain proteins in the body.

Investigated diseases

HER2-Positive Early Breast Cancer – HER2-positive early breast cancer is a type of breast cancer characterized by the overexpression of the human epidermal growth factor receptor 2 (HER2) protein. This overexpression leads to rapid growth and division of cancer cells. The disease typically begins in the breast tissue and can spread to nearby lymph nodes. In its early stages, it may not cause noticeable symptoms, but as it progresses, it can lead to changes in breast shape, size, or appearance. The progression of the disease can vary, with some cases remaining localized while others may advance more quickly. Monitoring and management are crucial to address the changes in the disease's progression.
Trial detailsLast updated 9 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509321-50-00Protocol codeML42502Estimated enrolment34 patientsSponsorRoche Farma S.A.

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