HER2-positive Breast CancerNCT01722890
CharactHer. ICORG 12-09, V3
An observational study of HER2-positive Breast Cancer and TNM Stage II-IV Breast Cancer, run by Cancer Trials Ireland at 2 sites in 2 countries.
Trial summary
Primary Objective: The primary aim of the study is: 1.To identify and validate a panel of molecular and cytogenetic biomarkers able to predict Durable Complete Response (DCR) after chemotherapy and trastuzumab in patients with HER2-positive locally advanced or metastatic breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HER2-positive Breast Cancer, TNM Stage II-IV Breast Cancer
- Type of treatment
- Injection or infusion
- How many people
- 130 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2012to 27 Jan 2021
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population will consist of two separate cohorts of patients with HER2-positive breast cancer that will be analysed based on their responsiveness to trastuzumab-containing chemotherapy. Cohort 1 will include patients with TNM stage II-IV breast cancer with highly trastuzumab-sensitive tumours. Results of laboratory analyses from Cohort 1 will be matched with those from Cohort 2 (Control group) that includes patients at the same TNM clinical stages but with trastuzumab-refractory disease.
Who may be able to join
- Histologically proven AJCC TNM stage II-IV invasive breast cancer
- HER2-positivity defined as score 3+ on IHC and/or with HER2/neu amplification on FISH test (HER2/CEP17 ratio >2.0 on PathVysion test)
- Evidence of complete response (CR) according to RECIST 1.1 criteria lasting for at least 36 months (for stage IV patients only) following a first-line chemotherapy and trastuzumab
- Pathological Complete Response (pCR) following a neo-adjuvant chemotherapy (CT) and trastuzumab (for stage II-III patients only). pCR is defined as no evidence of residual invasive carcinoma in the breast (ductal carcinoma in situ (DCIS) is allowed) AND in all the examined lymph nodes (micro-metastases and isolated tumour cells are not allowed).
- At least one FFPE archived tissue sample from the primary tumour and/or a metastatic site(s) available for laboratory analyses
- Adequate follow up information
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- Histologically proven AJCC TNM stage II-IV invasive breast cancer
- HER2-positivity defined as score 3+ on IHC and/or with HER2/neu amplification on FISH test (HER2/CEP17 ratio>2.0 on PathVysion test)
- Progression of disease according to RECIST 1.1 while receiving trastuzumab (in association with chemotherapy or as single agent as maintenance therapy) or within 6 months from last dose of trastuzumab (for stage IV patients only)
- Residual invasive tumour in the breast larger than 2cm and /or at least one micro- or macro-metastasis in the axillary lymph nodes following pre-operative trastuzumab-containing chemotherapy (for stage II-III patients only)
- At least one FFPE archived tissue sample from the primary tumour and/or a metastatic site(s) available for laboratory analyses
- Adequate follow up information
Who cannot join
- 1. Any deviation from the above mentioned Inclusion criteria
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: CharactHer: A Study of the Molecular and Cytogenetic Characteristics of HER2-positive Breast Cancers to Predict Durable Complete Response After Chemotherapy and Trastuzumab
Primary Objective:
The primary aim of the study is:
1.To identify and validate a panel of molecular and cytogenetic biomarkers able to predict Durable Complete Response (DCR) after chemotherapy and trastuzumab in patients with HER2-positive locally advanced or metastatic breast cancer.
Secondary Objective:
The secondary aims of the study are:
- To perform a comprehensive exploration of the molecular and cytogenetic characteristics of DCR patients to identify any possible correlation between the tumour's biological and cytogenetic characteristics and the degree of clinical response to trastuzumab;
- To produce data in preparation for further translational studies on HER2-positive breast cancer.
Read the detailed description
Type of Study: Translational
This is a pilot retrospective laboratory-based cohort study.
Eligible patients will be identified at each one of the participating institutions by a systematic cross-matching of the datasets of Medical Oncology, Pathology and Pharmacy Departments.
Patient Population:
Cohort 1: TNM stage II-IV breast cancer patients with highly trastuzumab-sensitive tumours.
Cohort 2: (Control group) TNM stage II-IV breast cancer patients with trastuzumab-refractory disease.
- Keywords
- HER2-positive breast cancer, durable complete response, cytogenetic characteristics, molecular characteristics, trastuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | TNM stage II-IV breast cancer patients with highly trastuzumab-sensitive tumours. | |
| Cohort 2(Control Group) | TNM stage II-IV breast cancer patients with trastuzumab-refractory disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Panel of molecular and cytogenetic biomarkers able to predict Durable Complete Response (DCR) after chemotherapy and trastuzumab in patients with HER2-positive locally advanced or metastatic breast cancer.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startJul 2012
- Primary completion27 Jan 2021
- Study completion27 Jan 2021
Why it stopped: As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.
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 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
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Giuseppe Gullo, Medicine and Surgery, Principal investigator, St Vincent's University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722890
- Sponsor's protocol ID
- ICORG 12-09
- Status last verified
- Jul 2025
- First submitted
- 25 Oct 2012
- Last updated
- 8 Jul 2025
- Results posted
- No
Publications
Walsh N, Andrieu C, O'Donovan P, Quinn C, Maguire A, Furney SJ, Gullo G, Crown J. Whole-exome sequencing of long-term, never relapse exceptional responders of trastuzumab-treated HER2+ metastatic breast cancer. Br J Cancer. 2020 Oct;123(8):1219-1222. doi: 10.1038/s41416-020-0999-z. Epub 2020 Jul 27.
PubMed 32713940
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CharactHer: A Study of the Molecular and Cytogenetic Characteristics of HER2-positive Breast Cancers to Predict Durable Complete Response After Chemotherapy and Trastuzumab
- ClinicalTrials.gov ID
- NCT01722890
- Acronym / sponsor ID
- ICORG 12-09
- Keywords
- HER2-positive breast cancer, durable complete response, cytogenetic characteristics, molecular characteristics, trastuzumab
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Jul 2012 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 7 Nov 2012 (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.
Primary Objective:
The primary aim of the study is:
1.To identify and validate a panel of molecular and cytogenetic biomarkers able to predict Durable Complete Response (DCR) after chemotherapy and trastuzumab in patients with HER2-positive locally advanced or metastatic breast cancer.
Secondary Objective:
The secondary aims of the study are:
- To perform a comprehensive exploration of the molecular and cytogenetic characteristics of DCR patients to identify any possible correlation between the tumour's biological and cytogenetic characteristics and the degree of clinical response to trastuzumab;
- To produce data in preparation for further translational studies on HER2-positive breast cancer.
Detailed description
Type of Study: Translational
This is a pilot retrospective laboratory-based cohort study.
Eligible patients will be identified at each one of the participating institutions by a systematic cross-matching of the datasets of Medical Oncology, Pathology and Pharmacy Departments.
Patient Population:
Cohort 1: TNM stage II-IV breast cancer patients with highly trastuzumab-sensitive tumours.
Cohort 2: (Control group) TNM stage II-IV breast cancer patients with trastuzumab-refractory disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –TNM stage II-IV breast cancer patients with highly trastuzumab-sensitive tumours. |
| Cohort 2(Control Group) | – | –TNM stage II-IV breast cancer patients with trastuzumab-refractory disease. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population will consist of two separate cohorts of patients with HER2-positive breast cancer that will be analysed based on their responsiveness to trastuzumab-containing chemotherapy. Cohort 1 will include patients with TNM stage II-IV breast cancer with highly trastuzumab-sensitive tumours. Results of laboratory analyses from Cohort 1 will be matched with those from Cohort 2 (Control group) that includes patients at the same TNM clinical stages but with trastuzumab-refractory disease.
Key inclusion criteria (12 listed)
- Histologically proven AJCC TNM stage II-IV invasive breast cancer
- HER2-positivity defined as score 3+ on IHC and/or with HER2/neu amplification on FISH test (HER2/CEP17 ratio >2.0 on PathVysion test)
- Evidence of complete response (CR) according to RECIST 1.1 criteria lasting for at least 36 months (for stage IV patients only) following a first-line chemotherapy and trastuzumab
- Pathological Complete Response (pCR) following a neo-adjuvant chemotherapy (CT) and trastuzumab (for stage II-III patients only). pCR is defined as no evidence of residual invasive carcinoma in the breast (ductal carcinoma in situ (DCIS) is allowed) AND in all the examined lymph nodes (micro-metastases and isolated tumour cells are not allowed).
- At least one FFPE archived tissue sample from the primary tumour and/or a metastatic site(s) available for laboratory analyses
Key exclusion criteria (1 listed)
- 1. Any deviation from the above mentioned Inclusion criteria
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
Panel of molecular and cytogenetic biomarkers able to predict Durable Complete Response (DCR) after chemotherapy and trastuzumab in patients with HER2-positive locally advanced or metastatic breast cancer.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Derived from this study: PubMed 32713940Walsh N, Andrieu C, O'Donovan P, Quinn C, Maguire A, Furney SJ, Gullo G, Crown J. Whole-exome sequencing of long-term, never relapse exceptional responders of trastuzumab-treated HER2+ metastatic breast cancer. Br J Cancer. 2020 Oct;123(8):1219-1222. doi: 10.1038/s41416-020-0999-z. Epub 2020 Jul 27.
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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. This study is not recruiting at the moment.
Giuseppe Gullo, Medicine and Surgery principal investigator
St Vincent's University Hospital, Ireland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-positive Breast Cancer and TNM Stage II-IV Breast Cancer, run by Cancer Trials Ireland at 2 sites in 2 countries.
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 12 inclusion and 1 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: stopped early, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland, 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?
The study was stopped early (reason given: As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.). Results are not available in the source record.
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?
Panel of molecular and cytogenetic biomarkers able to predict Durable Complete Response (DCR) after chemotherapy and trastuzumab in patients with HER2-positive locally advanced or metastatic breast cancer. (time frame: 2 years). 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 NCT01722890, 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 8 Jul 2025.