Clinical trial · Observational
CharactHer. ICORG 12-09, V3
CharactHer: A Study of the Molecular and Cytogenetic Characteristics of HER2-positive Breast Cancers to Predict Durable Complete Response After Chemotherapy and Trastuzumab
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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: 1. 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; 2. To produce data in preparation for further translational studies on HER2-positive breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| TNM Stage II-IV Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- TNM stage II-IV breast cancer patients with highly trastuzumab-sensitive tumours.
- label
- Cohort 2(Control Group)
- description
- TNM stage II-IV breast cancer patients with trastuzumab-refractory disease.
Primary outcomes (1)
- 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.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWalsh 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. PMID 32713940