Advanced Metastatic Breast CancerLEGONCT06706557
Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced/Metastatic Breast Cancer
An observational study of Advanced Metastatic Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
A Pilot study on circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Metastatic Breast Cancer
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jan 2024to 31 Dec 2030
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)
Who may be able to join
- Participants diagnosed with HER2-low breast cancer, defined as IHC score 1+ or 2+ and not amplified at in situ hybridization (ISH) test as confirmed by local laboratory testing.
- Participants should be at advanced or metastatic setting prior to treatment.
- Written informed consent (Accordo di Partecipazione alla Ricerca Scientifica) and specific informed consent to the study must be signed and dated by the patient and the doctor prior to inclusion.
- Patients must be accessible for follow-up.
Who cannot join
None listed.
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
European Institute of Oncology
Milan, MI, 20141
Nicola Fusco, MD, 00390294372079, nicola.fusco@ieo.it
About this study
Official title: A Pilot Study on the Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced/Metastatic Breast Cancer
A Pilot study on circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)
Read the detailed description
Prospective single-center feasibility study of 30 patients with carcinoma breast with low levels of HER2 expression, defined as 1+ or 2+ expression levels by the IHC technique (immunohistochemistry) and the gene not amplified by the ISH test (in situ hybridization)
- Conditions
- Advanced Metastatic Breast Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)
evaluate the mutations present in breast cancer of patients with advanced/metastatic disease e HER2-low defined with 1+ or 2+ expression levels by IHC (immunohistochemistry) technique and gene not amplified by ISH test (in situ hybridization)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start11 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Metastatic Breast CancerStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicola Fusco, MD, Principal investigator, Istituto Europeo di Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706557
- Sponsor's protocol ID
- IEO 1990
- Acronym
- LEGO
- Status last verified
- Mar 2026
- First submitted
- 22 Nov 2024
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced/Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06706557
- Acronym / sponsor ID
- LEGO / IEO 1990
- Conditions
- Advanced Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 26 Nov 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.
A Pilot study on circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)
Detailed description
Prospective single-center feasibility study of 30 patients with carcinoma breast with low levels of HER2 expression, defined as 1+ or 2+ expression levels by the IHC technique (immunohistochemistry) and the gene not amplified by the ISH test (in situ hybridization)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)
Key inclusion criteria (4 listed)
- Participants diagnosed with HER2-low breast cancer, defined as IHC score 1+ or 2+ and not amplified at in situ hybridization (ISH) test as confirmed by local laboratory testing.
- Participants should be at advanced or metastatic setting prior to treatment.
- Written informed consent (Accordo di Partecipazione alla Ricerca Scientifica) and specific informed consent to the study must be signed and dated by the patient and the doctor prior to inclusion.
- Patients must be accessible for follow-up.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)
Time frame: 12 months
evaluate the mutations present in breast cancer of patients with advanced/metastatic disease e HER2-low defined with 1+ or 2+ expression levels by IHC (immunohistochemistry) technique and gene not amplified by ISH test (in situ hybridization)
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 24 Mar 2026.
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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.
Nicola Fusco, MD 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 Advanced Metastatic Breast Cancer, 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 4 inclusion and 0 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 24 Mar 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 Nicola Fusco, MD (00390294372079, nicola.fusco@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low) (time frame: 12 months). 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 24 Mar 2026.