HER2-positive Breast CancerCRANIUMNCT06358625
Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer
An observational study of HER2-positive Breast Cancer, run by Center Eugene Marquis at 1 site in France.
Trial summary
HER2 gene amplification, detected in 20% to 30% of breast cancers, was a poor prognostic factor before the advent of anti-HER2 therapies. In the early 2000s, trastuzumab revolutionised the management of patients with HER2-positive (HER2+) breast cancer in the metastatic and localised stages of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Pre-treatment biopsy
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2024to 6 Jun 2031
- 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: women with HER2+ non-metastatic breast cancer treated at the CRLCC Eugène marquis
Who may be able to join
- Age ≥ 18 years old
- be a female patient
- Patients with histologically proven HER2-positive invasive breast cancer (IHC 3+ or 2+ with positive SISH),
- Neoadjuvant chemotherapy and intra-tumour clips indicated at the multidisciplinary consultation meeting (RCP).
- Signed Informed Consent Form
Who cannot join
- pregnant or breast-feeding women
- Have had a haematoma requiring level II analgesics at the time of the diagnostic biopsy.
- Known coagulation disorders
- Individual deprived of liberty or placed under the authority of a tutor, or a currator
- Not be affiliated to a social security regimen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre de lutte contre le cancer Eugène Marquis
Rennes, 35 000
Fanny LE DU, Dr
Fanny LE DU, DR
About this study
HER2 gene amplification, detected in 20% to 30% of breast cancers, was a poor prognostic factor before the advent of anti-HER2 therapies. In the early 2000s, trastuzumab revolutionised the management of patients with HER2-positive (HER2+) breast cancer in the metastatic and localised stages of the disease.
At the time of diagnosis of metastatic disease, 7-11% of patients have brain metastases, with (70% of cases) or without symptoms (30% of cases). In the absence of brain metastases, 30% to 50% of patients will develop brain metastases within the first two years of treatment, depending on whether the disease is hormone receptor positive (HR+) or negative (HR-).
Read more
The presence of brain metastases is the most important prognostic factor. The neurological symptoms caused by the presence of these lesions, but also by the local treatments offered, affect patients' quality of life, although improvements in surgical and radiotherapy techniques have significantly reduced the need for particularly toxic whole brain radiotherapy.
International guidelines do not recommend systematic brain MRI in the absence of neurological symptoms, either in the adjuvant or metastatic stages of this disease. However, there may be a role for more systematic and earlier screening for cerebral recurrence, as single cerebral recurrences without extracranial involvement are common and the new anti-HER2 agents (i.e. tucatinib, an anti-HER2 tyrosine kinase inhibitor, and T-Dxd) have shown significant objective response rates in cerebral metastases.
To date, no clinical or histological prognostic factor (proliferation index, HR expression, etc.) has been used to identify a population of patients at high risk of cerebral relapse, allowing monitoring and treatment to be personalised.
New tools for these indications would significantly modify our clinical practice, allowing the identification of a subpopulation at high risk of cerebral recurrence, suitable for increased monitoring and therapeutic adjustment.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Pre-treatment biopsy
- Keywords
- Metastases, Central Nervous System, Biopsy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-treatment biopsyOther
A breast biopsy is performed just before the "clip" is placed in the tumour and additional blood samples are performed.
| Study group | Role | What they receive |
|---|---|---|
| HER positive | The study will include an initial assessment and longitudinal and individual follow-up to identify the occurrence of clinical events of interest and to monitor the evolution of any tumour biomarkers on circulating tumour DNA. Receives: Other: Pre-treatment biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptomic profile change of HER2+ primary breast tumours before any treatment
comparison of the transcriptomic profile of HER2+ primary breast tumours before any treatment of patients who will develop brain metastases within 5 years with patients who will not develop them
Measured: At inclusion
Secondary outcomes (1)
Transcriptomic profile change on circulating tumour DNA (ctDNA)
High-throughput sequencing (NGS) of a panel of genes previously identified by transcriptomic analysis
Measured: At baseline, Year 1; Year2; Year3, Year4; Year 5, at relapse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start6 Jun 2024
- Primary completion6 Jun 2031 (estimated)
- Study completion6 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanny LE DU, Dr, Principal investigator, Centre de lutte contre le cancer Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358625
- Sponsor's protocol ID
- 2023-4-1-001
- Acronym
- CRANIUM
- Status last verified
- Jul 2025
- First submitted
- 2 Apr 2024
- Last updated
- 1 Aug 2025
- 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 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer
- ClinicalTrials.gov ID
- NCT06358625
- Acronym / sponsor ID
- CRANIUM / 2023-4-1-001
- Conditions
- HER2-positive Breast Cancer
- Keywords
- Metastases, Central Nervous System, Biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 6 Jun 2031 (estimated)
- Study completion
- 6 Jun 2031 (estimated)
- First posted
- 10 Apr 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.
HER2 gene amplification, detected in 20% to 30% of breast cancers, was a poor prognostic factor before the advent of anti-HER2 therapies. In the early 2000s, trastuzumab revolutionised the management of patients with HER2-positive (HER2+) breast cancer in the metastatic and localised stages of the disease.
At the time of diagnosis of metastatic disease, 7-11% of patients have brain metastases, with (70% of cases) or without symptoms (30% of cases). In the absence of brain metastases, 30% to 50% of patients will develop brain metastases within the first two years of treatment, depending on whether the disease is hormone receptor positive (HR+) or negative (HR-).
The presence of brain metastases is the most important prognostic factor. The neurological symptoms caused by the presence of these lesions, but also by the local treatments offered, affect patients' quality of life, although improvements in surgical and radiotherapy techniques have significantly reduced the need for particularly toxic whole brain radiotherapy.
International guidelines do not recommend systematic brain MRI in the absence of neurological symptoms, either in the adjuvant or metastatic stages of this disease. However, there may be a role for more systematic and earlier screening for cerebral recurrence, as single cerebral recurrences without extracranial involvement are common and the new anti-HER2 agents (i.e. tucatinib, an anti-HER2 tyrosine kinase inhibitor, and T-Dxd) have shown significant objective response rates in cerebral metastases.
To date, no clinical or histological prognostic factor (proliferation index, HR expression, etc.) has been used to identify a population of patients at high risk of cerebral relapse, allowing monitoring and treatment to be personalised.
New tools for these indications would significantly modify our clinical practice, allowing the identification of a subpopulation at high risk of cerebral recurrence, suitable for increased monitoring and therapeutic adjustment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER positive | – | Other: Pre-treatment biopsyThe study will include an initial assessment and longitudinal and individual follow-up to identify the occurrence of clinical events of interest and to monitor the evolution of any tumour biomarkers on circulating tumour DNA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with HER2+ non-metastatic breast cancer treated at the CRLCC Eugène marquis
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- be a female patient
- Patients with histologically proven HER2-positive invasive breast cancer (IHC 3+ or 2+ with positive SISH),
- Neoadjuvant chemotherapy and intra-tumour clips indicated at the multidisciplinary consultation meeting (RCP).
- Signed Informed Consent Form
Key exclusion criteria (5 listed)
- pregnant or breast-feeding women
- Have had a haematoma requiring level II analgesics at the time of the diagnostic biopsy.
- Known coagulation disorders
- Individual deprived of liberty or placed under the authority of a tutor, or a currator
- Not be affiliated to a social security regimen
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 |
|---|---|---|
| Pre-treatment biopsyA breast biopsy is performed just before the "clip" is placed in the tumour and additional blood samples are performed. | Other | HER positive |
Primary outcome
Transcriptomic profile change of HER2+ primary breast tumours before any treatment
Time frame: At inclusion
comparison of the transcriptomic profile of HER2+ primary breast tumours before any treatment of patients who will develop brain metastases within 5 years with patients who will not develop them
1 secondary outcome
Transcriptomic profile change on circulating tumour DNA (ctDNA)
Time frame: At baseline, Year 1; Year2; Year3, Year4; Year 5, at relapse
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 1 Aug 2025.
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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.
Fanny LE DU, Dr principal investigator
Centre de lutte contre le cancer Eugène Marquis
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 HER2-positive Breast Cancer, run by Center Eugene Marquis at 1 site in France.
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 5 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 1 Aug 2025. 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 France. 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 Valérie JOLAINE, Dr ((0)299253036 ext. +33, v.jolaine@rennes.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptomic profile change of HER2+ primary breast tumours before any treatment (time frame: At inclusion). 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 1 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.