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Study evaluating HER2DX-guided treatment in patients with early-stage HER2-positive breast cancer using trastuzumab, pertuzumab and combination chemotherapy

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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 studying a new diagnostic-guided treatment approach for patients with HER2-positive early breast cancer. The study will evaluate whether using a diagnostic test called HER2DX to guide treatment decisions can improve patients' quality of life while maintaining similar treatment effectiveness compared to standard care.

The main medications being tested include several cancer drugs: trastuzumab, pertuzumab, docetaxel, carboplatin, cyclophosphamide, doxorubicin, epirubicin, paclitaxel, and trastuzumab emtansine. These medications will be given through intravenous infusion or injection before surgery (neoadjuvant treatment). The treatment plan will be customized based on the results of the HER2DX test in one group of patients, while the other group will receive standard treatment.

The study will measure how treatment affects patients' overall health status and energy levels using quality of life questionnaires. It will also evaluate how well the tumors respond to treatment and monitor patients for any side effects. The trial is expected to last approximately three years.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medical assessment

    Your heart function will be checked through an echocardiogram or MUGA scan to ensure your heart is working at 50% or above

    A tissue sample from your breast tumor will be evaluated to confirm it is HER2-positive

  2. Step 2

    Neoadjuvant treatment phase

    You will receive treatment before surgery (neoadjuvant therapy) which includes several medications given through intravenous infusion:

    - Trastuzumab and pertuzumab (targeted therapies for HER2-positive breast cancer)

    - Paclitaxel or docetaxel (chemotherapy medications)

    - Carboplatin (chemotherapy medication)

    Some patients may receive doxorubicin and cyclophosphamide as part of their treatment

  3. Step 3

    Surgery

    After completing the neoadjuvant treatment, you will undergo surgery

    The surgery will include removal of breast tissue (partial or total mastectomy)

    Lymph nodes in the armpit area will also be removed for examination

  4. Step 4

    Post-surgery treatment

    Additional treatment may be given after surgery

    This may include trastuzumab emtansine (T-DM1), given through intravenous infusion

  5. Step 5

    Follow-up period

    Your health status will be monitored regularly

    Quality of life assessments will be conducted using questionnaires

    The total study duration extends until November 2028

Who can join the trial?

13 criteria

  • Must be at least 18 years old at the time of signing consent
  • Must have HER2-positive early breast cancer that has been recently diagnosed and not yet treated

  • Must have a tumor that is either:

    • Stage T1 with lymph node involvement, or
    • Stage T2-3 with or without lymph node involvement
  • Must have normal heart function (ejection fraction ≥ 50%)
  • Must be willing to undergo surgery after initial treatment
  • Must have adequate blood cell counts and organ function
  • Must have tumor tissue available for testing
  • Must have good physical ability status (ECOG score of 0-2, meaning able to perform most daily activities)

  • Must agree to use effective birth control methods during treatment and for several months after:

    • Women: for up to 12 months after treatment
    • Men: for up to 7 months after treatment
  • Cannot have cancer that has spread to other parts of the body (metastatic disease)
  • Must sign an informed consent form before any study procedures
  • Must be eligible to receive the study medications (including taxane, carboplatin, trastuzumab, pertuzumab, and T-DM1)
  • Can have multiple tumors in the breast if all are confirmed to be HER2-positive

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 75 years
  • Not having confirmed HER2-positive early breast cancer (a type of breast cancer where cancer cells have high levels of a protein called HER2)
  • Previous treatment with anti-HER2 therapy (medications targeting HER2 protein)
  • Currently participating in another clinical trial
  • Presence of metastatic disease (cancer that has spread to other parts of the body)
  • Pregnancy or breastfeeding
  • Serious heart conditions
  • Active infections requiring treatment
  • History of other cancers in the past 5 years (except successfully treated non-melanoma skin cancer or cervical cancer in situ)
  • Any medical condition that could interfere with the study treatment or assessment
  • Unable to provide informed consent
  • Mental conditions that could affect compliance with the study protocol
  • Known allergies to study medications
  • Abnormal laboratory values that could affect safety
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Investigated drugs

  • Trastuzumab

    is a targeted medicine known as a monoclonal antibody. It attaches to a protein called HER2, which is found in large amounts on the surface of some breast cancer cells, blocking the signals that tell the cancer cells to grow and helping the immune system destroy them. In this trial it is given either as an infusion into a vein or as an injection under the skin, and it forms the backbone of treatment for HER2-positive breast cancer.

  • Pertuzumab

    is another monoclonal antibody that also targets the HER2 protein, but it attaches to a different part of it than trastuzumab does. Used together with trastuzumab, it blocks the growth signals of HER2-positive breast cancer more completely. It is given as an infusion into a vein.

  • Phesgo

    is a ready-made combination of trastuzumab and pertuzumab in a single injection given under the skin. It works in the same way as the two antibodies given separately, but the injection takes only a few minutes instead of lengthy infusions, which makes treatment more convenient for patients.

  • Trastuzumab emtansine

    is an antibody-drug conjugate, meaning it combines the HER2-targeting antibody trastuzumab with a chemotherapy medicine attached to it. The antibody part finds the HER2-positive cancer cells and delivers the chemotherapy directly inside them, which helps destroy the cancer while limiting damage to healthy cells. It is given as an infusion into a vein.

  • Paclitaxel

    is a chemotherapy medicine from the taxane group. It works by stopping cancer cells from dividing, which causes them to die. In this trial it is given as an infusion into a vein, either in its standard form or as an albumin-bound form, in which the medicine is attached to a natural protein to help it dissolve and reach the tumour.

  • Docetaxel

    is another taxane chemotherapy medicine that works in a similar way to paclitaxel, blocking the ability of cancer cells to divide and multiply. It is given as an infusion into a vein and is commonly combined with targeted medicines in the treatment of breast cancer.

What is already known about the treatment

  • Cyclophosphamide

    Given by intravenous infusion, this drug is an approved chemotherapy used for many cancers including breast cancer. It works by adding a chemical group to DNA, which stops cancer cells from dividing. It belongs to the class of alkylating agents and is a standard part of many breast‑cancer treatment plans.

  • Epirubicin

    Administered as an intravenous infusion, epirubicin is an approved anthracycline chemotherapy for breast cancer. It inserts itself between DNA strands, preventing the cancer cells from copying their genetic material. This drug is classified as an anthracycline antibiotic and is commonly used in early‑stage HER2‑positive breast cancer regimens.

  • Trastuzumab emtansine

    Delivered as a solution for infusion, trastuzumab emtansine is an approved antibody‑drug conjugate for HER2‑positive breast cancer. It combines a HER2‑targeting antibody with a chemotherapy payload, allowing the drug to be carried directly to cancer cells. It is classified as an antibody‑drug conjugate and provides a focused way to kill HER2‑positive tumors.

  • Paclitaxel

    Given by intravenous infusion, paclitaxel is an approved chemotherapy used in breast cancer treatment. It stabilizes cell structures called microtubules, which blocks cancer cells from dividing. Paclitaxel belongs to the taxane class of drugs and is a common component of HER2‑positive breast‑cancer therapy.

  • Doxorubicin

    Administered through intravenous infusion, doxorubicin is an approved anthracycline chemotherapy for breast cancer. It intercalates into DNA and generates free radicals that damage cancer cells. It is classified as an anthracycline antibiotic and is widely used in standard breast‑cancer regimens.

  • Docetaxel

    Delivered by intravenous infusion, docetaxel is an approved taxane chemotherapy for breast cancer. It promotes the assembly of microtubules and prevents their breakdown, stopping cancer cells from multiplying. This medication is part of the taxane class and is often used in HER2‑positive breast‑cancer treatment plans.

Investigated diseases

HER2-positive breast cancer - A type of breast cancer that occurs when breast cells have too many copies of the HER2 gene, making excessive amounts of the HER2 protein. This protein promotes cell growth and division, leading to faster tumor development. HER2-positive breast cancer typically develops in the early stages as abnormal cells in the breast ducts or lobules. The cancer cells in this type tend to grow and divide more aggressively than other types of breast cancer. The disease begins in the breast tissue and can affect either men or women, though it is more common in women.
Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521040-37-00Protocol codeHCB-ONC002Estimated enrolment224 patientsSponsorFundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

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