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 study about?

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.

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 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 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 Post-surgery treatment

Additional treatment may be given after surgery

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
Centre Jean Perrin	Clermont Ferrand	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Clinique Pasteur	Toulouse	France
Hospital Universitario De Salamanca	Salamanca	Spain

Other Sites

Site Name	City	Country
Klinikum Dortmund gGmbH	Dortmund	Germany
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH	Schweinfurt	Germany
University Hospital Waterford	Waterford	Ireland
Hospital Universitario Basurto	Bilbao	Spain
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH	Moenchengladbach	Germany
Marienhospital Bottrop gGmbH	Bottrop	Germany
Hospital Universitario De Leon	Leon	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Kliniken der Stadt Koeln gGmbH	Cologne	Germany
Salut Sant Joan De Reus	Reus	Spain
Polyclinique Bordeaux Nord Aquitaine	Bordeaux	France
Institut Sainte Catherine	Avignon	France
Centre Francois Baclesse	Caen	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Ckga Ulbplzgoyd Hspbukfq	Cork	Ireland
Iguszyxq Clzgrl Dqdvohmnpcujoeeok	L'hospitalet De Llobregat	Spain
Vwrsz Cxocneyhobp Kjqeufhb Klzggbgkm	Karlsruhe	Germany
Hqkgjxaepayscorc io Mnurglb	Bremen	Germany
Gahbtdwlatxzmblv Zbfrtzn Bilh	Bonn	Germany
Cpryzf Lewv Bkbask	Lyon	France
Inanprrs Pymeqlituodrnyr Cehots Cypdwx	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.09.2025
Germany	Not yet recruiting	01.09.2025
Ireland	Not yet recruiting	01.09.2025
Spain	Not yet recruiting	01.09.2025

Trial locations

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.

Investigated diseases:

HER2 positive breast cancer

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 ID:

2025-521040-37-00

Protocol code:

HCB-ONC002

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?