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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 April 2023 |
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Main ID: |
NCT01722890 |
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Date of registration:
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25/10/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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CharactHer. ICORG 12-09, V3
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Scientific title:
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CharactHer: A Study of the Molecular and Cytogenetic Characteristics of HER2-positive Breast Cancers to Predict Durable Complete Response After Chemotherapy and Trastuzumab |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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130 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01722890 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Ireland
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Italy
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Contacts
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Name:
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Giuseppe Gullo, Medicine and Surgery |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Vincent's University Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria for Cohort 1:
1. Histologically proven AJCC TNM stage II-IV invasive breast cancer
2. 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)
3. 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
4. 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).
5. At least one FFPE archived tissue sample from the primary tumour and/or a metastatic
site(s) available for laboratory analyses
6. Adequate follow up information
Inclusion criteria for Cohort 2:
1. Histologically proven AJCC TNM stage II-IV invasive breast cancer
2. 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)
3. 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)
4. 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)
5. At least one FFPE archived tissue sample from the primary tumour and/or a metastatic
site(s) available for laboratory analyses
6. Adequate follow up information
Exclusion Criteria:
1. Any deviation from the above mentioned Inclusion criteria
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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HER2-positive Breast Cancer
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TNM Stage II-IV Breast Cancer
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Primary Outcome(s)
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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]
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Secondary ID(s)
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ICORG 12-09
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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