Untreated Human Epidermal Growth Factor Receptor-2(HER2)Positive Early Breast CancerHERBINNCT01834950
Identification of Early Markers of Response and Resistance to Trastuzumab
A study testing Blood test in people with Untreated Human Epidermal Growth Factor Receptor-2(HER2)Positive Early Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
The study is a single arm prospective study, aiming at identifying biomarkers of early response to trastuzumab. It is a prognostic factor study recruiting all consecutive cases of HER-2 positive breast cancer eligible for a pre-operative treatment by trastuzumab, followed by breast conserving surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Untreated Human Epidermal Growth Factor Receptor-2(HER2)Positive Early Breast Cancer
- What is being tested?
- Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2013to 10 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Signed written informed consent
- Female patients aged 18 years or older.
- Histologically or confirmed untreated invasive carcinoma of the breast
- Previous treated invasive breast carcinoma or ductal carcinoma in situ are allowed, assuming there is no evidence of disease at the moment of the inclusion in the protocol, and patients are not on any current treatment
- Candidates for breast conserving surgery: patients with a minimum size of 11 mm measured by breast US. Bilateral and multifocal tumors are allowed, assuming the biopsies pre- and post-treatment are performed in the same target lesion.
- HER2-positive (defined as either immunohistochemistry [immuno-histochemistry ] 3+ or in situ hybridization [ISH] positive) as assessed by local laboratory on primary tumor (ISH positivity is defined as a ratio of 2.2 or greater for the number of HER2 gene copies to the number of signals for abnormality on chromosome 17 (CEP17), or for single probe tests, a HER2 gene count greater than 4) and/or by PCR.
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- No evidence of metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0/1.
- Left ventricular ejection fraction (LVEF) of at least 50%
- Negative pregnancy test in women of childbearing potential (premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization).
- For women of childbearing potential who are sexually active, agreement to use a highly effective, non-hormonal form of contraception or two effective forms of non-hormonal contraception during and for at least 6 months post-treatment.
- Maximum time allowed between collect of the informed consent and first administration of treatment :21 days
- All patients candidates for initial surgery and not candidates for primary chemotherapy (T3 acceptable if multifocal and decision primary surgery).
Who cannot join
- Patients non-candidate for initial breast surgery or patient's candidate for neoadjuvant chemotherapy ;
- Patients receiving another concomitant anticancer treatment like chemotherapy, immunotherapy, anti-HER2 treatment other than trastuzumab, endocrine treatment, or radiotherapy ;
- Known hypersensibility to trastuzumab ;
- Serious uncontrolled concomitant disease that would contraindicate the use of trastuzumab or that would put the patient at high risk for treatment-related complications ;
- Inadequate organ function, evidenced by the following laboratory results:
- Absolute neutrophil count <1,500 cells/mm3
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- Platelet count <100,000 cells/mm3
- Hemoglobin <9 g/dL
- Total bilirubin greater than the upper limit of normal (ULN) (unless the patient has documented Gilbert's syndrome)
- Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) >2.5 x ULN
- Serum creatinine >2.0 mg/dL or 177 μmol/L
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) >1.5 x ULN (unless on therapeutic coagulation)
- Uncontrolled hypertension (systolic >150 mmHg and/or diastolic > 100 mmHg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication; unstable angina; CHF of New York Heart Association (NYHA) Grade II or higher; or serious cardiac arrhythmia requiring medication ;
- Current known infection with human immunodeficiency virus (HIV), hepatitis B or C virus ;
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol ;
- Pregnant or breastfeeding patients ;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Early Markers of Response and Resistance to Trastuzumab in Patients With Localized Human Epidermal Growth Factor Receptor-2(HER-2)-Positive Breast Cancer Candidates for Breast Conserving Surgery
The study is a single arm prospective study, aiming at identifying biomarkers of early response to trastuzumab. It is a prognostic factor study recruiting all consecutive cases of HER-2 positive breast cancer eligible for a pre-operative treatment by trastuzumab, followed by breast conserving surgery. The investigators will study the association between the value of biomarkers measured at diagnosis and the Response Evaluation Criteria in Solid Tumors response (partial and complete response) using a logistic regression (main analysis).
- Being tested
- Blood test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab | Experimental | The study is a single arm prospective study, aiming at identifying biomarkers of early response to trastuzumab Receives: Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
The response after 2 cycles of 3-weekly trastuzumab will be assessed as per Response Evaluation Criteria in Solid Tumors(RECIST) 1.1 criteria and will be correlated with biomarkers.
Measured: assessed after 6 weeks
Secondary outcomes (1)
Pathological complete response
According to Chevallier's classification
Measured: assessed after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study start27 Mar 2013
- Primary completion10 Dec 2017
- Study completion10 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Untreated Human Epidermal Growth Factor Receptor-2(HER2)Positive Early Breast CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834950
- Sponsor's protocol ID
- 2012-A01364-39
- Other IDs
- 2012/1909
- Acronym
- HERBIN
- Status last verified
- Aug 2026
- First submitted
- 1 Mar 2013
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodriguez C, Suciu V, Poterie A, Lacroix L, Miran I, Boichard A, Delaloge S, Deneuve J, Azoulay S, Mathieu MC, Valent A, Michiels S, Arnedos M, Vielh P. Concordance between HER-2 status determined by qPCR in Fine Needle Aspiration Cytology (FNAC) samples compared with IHC and FISH in Core Needle Biopsy (CNB) or surgical specimens in breast cancer patients. Mol Oncol. 2016 Nov;10(9):1430-1436. doi: 10.1016/j.molonc.2016.07.009. Epub 2016 Aug 5.
PubMed 27555543
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Early Markers of Response and Resistance to Trastuzumab in Patients With Localized Human Epidermal Growth Factor Receptor-2(HER-2)-Positive Breast Cancer Candidates for Breast Conserving Surgery
- ClinicalTrials.gov ID
- NCT01834950
- Acronym / sponsor ID
- HERBIN / 2012-A01364-39
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 27 Mar 2013 (actual)
- Primary completion
- 10 Dec 2017 (actual)
- Study completion
- 10 Dec 2017 (actual)
- First posted
- 18 Apr 2013 (estimated)
- 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.
The study is a single arm prospective study, aiming at identifying biomarkers of early response to trastuzumab. It is a prognostic factor study recruiting all consecutive cases of HER-2 positive breast cancer eligible for a pre-operative treatment by trastuzumab, followed by breast conserving surgery. The investigators will study the association between the value of biomarkers measured at diagnosis and the Response Evaluation Criteria in Solid Tumors response (partial and complete response) using a logistic regression (main analysis).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab | Experimental | Other: Blood testThe study is a single arm prospective study, aiming at identifying biomarkers of early response to trastuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed written informed consent
- Female patients aged 18 years or older.
- Histologically or confirmed untreated invasive carcinoma of the breast
- Previous treated invasive breast carcinoma or ductal carcinoma in situ are allowed, assuming there is no evidence of disease at the moment of the inclusion in the protocol, and patients are not on any current treatment
- Candidates for breast conserving surgery: patients with a minimum size of 11 mm measured by breast US. Bilateral and multifocal tumors are allowed, assuming the biopsies pre- and post-treatment are performed in the same target lesion.
Key exclusion criteria (16 listed)
- Patients non-candidate for initial breast surgery or patient's candidate for neoadjuvant chemotherapy ;
- Patients receiving another concomitant anticancer treatment like chemotherapy, immunotherapy, anti-HER2 treatment other than trastuzumab, endocrine treatment, or radiotherapy ;
- Known hypersensibility to trastuzumab ;
- Serious uncontrolled concomitant disease that would contraindicate the use of trastuzumab or that would put the patient at high risk for treatment-related complications ;
- Inadequate organ function, evidenced by the following laboratory results:
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 |
|---|---|---|
| Blood test | Other | Trastuzumab |
Primary outcome
Response rate
Time frame: assessed after 6 weeks
The response after 2 cycles of 3-weekly trastuzumab will be assessed as per Response Evaluation Criteria in Solid Tumors(RECIST) 1.1 criteria and will be correlated with biomarkers.
1 secondary outcome
Pathological complete response
Time frame: assessed after 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Results publication: PubMed 27555543Rodriguez C, Suciu V, Poterie A, Lacroix L, Miran I, Boichard A, Delaloge S, Deneuve J, Azoulay S, Mathieu MC, Valent A, Michiels S, Arnedos M, Vielh P. Concordance between HER-2 status determined by qPCR in Fine Needle Aspiration Cytology (FNAC) samples compared with IHC and FISH in Core Needle Biopsy (CNB) or surgical specimens in breast cancer patients. Mol Oncol. 2016 Nov;10(9):1430-1436. doi: 10.1016/j.molonc.2016.07.009. Epub 2016 Aug 5.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test in people with Untreated Human Epidermal Growth Factor Receptor-2(HER2)Positive Early Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris 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 13 inclusion and 16 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: finished, as of the sponsor's last update on 17 Aug 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: assessed after 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01834950, which also lists 1 linked publication.
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 17 Aug 2026.