Breast Cancer Early Stage Breast Cancer (Stage 1-3)HER2BREASTDXNCT06723990
Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX
An observational study of Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by European Institute of Oncology at 1 site in Italy.
Trial summary
To prospectively evaluate the impact of HER2DX on the decision-making processes of the treating physicians and especially among the routine multidisciplinary tumour board, in defining type and setting of systemic therapy administration in patients with stage I-III HER2+ BC, and the degree of clinician's confidence in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- Neoadjuvant standard treatment for HER2+ and Adjuvant standard treatment for HER2+
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 24 Oct 2024to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HER2 positive breast cancer patients with stage I-III
Who may be able to join
- Patients ≥ 18 years of age;
- Histologically confirmed HER2+ breast cancer;
- Stage I-III breast cancer without evidence of distant metastases;
- Being candidate to neoadjuvant/adjuvant therapy and locoregional treatment (surgery +/- radiotherapy);
- Written informed consent, signed by the patient, to study-specific procedures (the consent will consist of 2 levels: level 1 specifically for patients enrolled in the primary endpoint cohort and level 2 for all patients);
Who cannot join
- HER2- BC;
- Stage IV breast cancer;
- Lack of informed consent because of patient's incapable of discernment or unwilling to participate;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Europeo di Oncologia
Milan, Italy
Carmen Criscitiello, 00390294372689, carmen.criscitiello@ieo.it
About this study
Official title: Prospective Observational Monocentric Study to Evaluate the Impact of the HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2-BREAST-DX
To prospectively evaluate the impact of HER2DX on the decision-making processes of the treating physicians and especially among the routine multidisciplinary tumour board, in defining type and setting of systemic therapy administration in patients with stage I-III HER2+ BC, and the degree of clinician's confidence in the treatment recommendation.
- Being tested
- Neoadjuvant standard treatment for HER2+, Adjuvant standard treatment for HER2+
- Keywords
- HER2 positive breast cancer patients with stage I-III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant standard treatment for HER2+Drug
NEOADJUVANT SETTING
Adjuvant standard treatment for HER2+Drug
ADJUVANT SETTING
| Study group | Role | What they receive |
|---|---|---|
| NEOADJUVANT SETTING | Neoadjuvant standard treatment for HER2+: A→Tax +T/P Receives: Drug: Neoadjuvant standard treatment for HER2+ | |
| ADJUVANT SETTING | Adjuvant standard treatment for HER2+ (N0): Tax + T (+/-ET); Adjuvant standard treatment for HER2+ (N+): A→Tax +T/P (+/- ET) Receives: Drug: Adjuvant standard treatment for HER2+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of HER2DX on the decision-making processes of the treating physicians and multidisciplinary tumour board, in patients with stage I-III HER2+ BC
To prospectively evaluate the impact of HER2DX on the decision-making processes of the treating physicians and especially among the routine multidisciplinary tumour board, in defining type and setting of systemic therapy administration in patients with stage I-III HER2+ BC, and the degree of clinician's confidence in the treatment recommendation.
Measured: from baseline to the end of treatment at 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start24 Oct 2024
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paola Zagami, Principal investigator, Istituto Europeo di Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723990
- Sponsor's protocol ID
- UID 4259
- Acronym
- HER2BREASTDX
- Status last verified
- Feb 2026
- First submitted
- 27 Nov 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Monocentric Study to Evaluate the Impact of the HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2-BREAST-DX
- ClinicalTrials.gov ID
- NCT06723990
- Acronym / sponsor ID
- HER2BREASTDX / UID 4259
- Keywords
- HER2 positive breast cancer patients with stage I-III
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To prospectively evaluate the impact of HER2DX on the decision-making processes of the treating physicians and especially among the routine multidisciplinary tumour board, in defining type and setting of systemic therapy administration in patients with stage I-III HER2+ BC, and the degree of clinician's confidence in the treatment recommendation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEOADJUVANT SETTING | – | Drug: Neoadjuvant standard treatment for HER2+Neoadjuvant standard treatment for HER2+: A→Tax +T/P |
| ADJUVANT SETTING | – | Drug: Adjuvant standard treatment for HER2+Adjuvant standard treatment for HER2+ (N0): Tax + T (+/-ET); Adjuvant standard treatment for HER2+ (N+): A→Tax +T/P (+/- ET) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HER2 positive breast cancer patients with stage I-III
Key inclusion criteria (5 listed)
- Patients ≥ 18 years of age;
- Histologically confirmed HER2+ breast cancer;
- Stage I-III breast cancer without evidence of distant metastases;
- Being candidate to neoadjuvant/adjuvant therapy and locoregional treatment (surgery +/- radiotherapy);
- Written informed consent, signed by the patient, to study-specific procedures (the consent will consist of 2 levels: level 1 specifically for patients enrolled in the primary endpoint cohort and level 2 for all patients);
Key exclusion criteria (3 listed)
- HER2- BC;
- Stage IV breast cancer;
- Lack of informed consent because of patient's incapable of discernment or unwilling to participate;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant standard treatment for HER2+NEOADJUVANT SETTING | Drug | NEOADJUVANT SETTING |
| Adjuvant standard treatment for HER2+ADJUVANT SETTING | Drug | ADJUVANT SETTING |
Primary outcome
Impact of HER2DX on the decision-making processes of the treating physicians and multidisciplinary tumour board, in patients with stage I-III HER2+ BC
Time frame: from baseline to the end of treatment at 12 month
To prospectively evaluate the impact of HER2DX on the decision-making processes of the treating physicians and especially among the routine multidisciplinary tumour board, in defining type and setting of systemic therapy administration in patients with stage I-III HER2+ BC, and the degree of clinician's confidence in the treatment recommendation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
Related trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)
RecruitingPhase 2
FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Enrolling by invitation
Symptom Monitoring Using Patient-Report to Improve Medication Use
Breast Cancer Early Stage Breast Cancer (Stage 1-3), Endocrine Therapy
Recruiting
Evaluation of the Effect of Regular Physical Exercise in Breast Cancer.
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Not yet recruiting
PRISM Trial: Partial Breast Versus Whole Breast Radiation in Early Breast Cancer
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
Breast Neoplasms, Triple Negative Breast Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paola Zagami principal investigator
Istituto Europeo di Oncologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Zagami (00390294372437, paola.zagami@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of HER2DX on the decision-making processes of the treating physicians and multidisciplinary tumour board, in patients with stage I-III HER2+ BC (time frame: from baseline to the end of treatment at 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.