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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

Based on the provided trial data, I cannot identify any specific medications or therapies to list, as the source data does not contain information about specific treatments. The trial appears to be comparing HER2DX-guided treatment (which is a diagnostic approach) versus standard of care for HER2-positive breast cancer, but the actual medications or therapies are not specified in the provided data. If you'd like me to list the medications or therapies involved in this trial, I would need additional data that includes the specific treatments being used.

What is already known about the treatment

Since no specific medications are mentioned in the provided trial data, I cannot create medication descriptions in the requested format. The trial data only mentions that it's related to HER2-positive early breast cancer treatment and focuses on the HER2DX diagnostic tool for treatment guidance, but doesn't specify any particular medications. If you'd like medication descriptions, please provide information about specific medications used in the trial.

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 2 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

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).