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CharactHer. ICORG 12-09, V3

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ClinicalTrials.gov Identifier: NCT01722890
Recruitment Status : Recruiting
First Posted : November 7, 2012
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

Brief 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.

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.

Condition or disease
HER2-positive Breast Cancer TNM Stage II-IV 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 Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Study Start Date : July 2012
Estimated Primary Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Group/Cohort
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.



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722890


Locations
Ireland
St. Vincents University Hospital Recruiting
Dublin, Ireland
Contact: Contact Person    +353 1 221 4000      
Italy
Humanitas Cancer Centre Milan Not yet recruiting
Milan, Italy
Contact: Contact Person         
Sponsors and Collaborators
Cancer Trials Ireland
Investigators
Principal Investigator: Giuseppe Gullo, Medicine and Surgery St. Vincent's University Hospital

Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT01722890     History of Changes
Other Study ID Numbers: ICORG 12-09
First Posted: November 7, 2012    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

Keywords provided by Cancer Trials Ireland:
HER2-positive breast cancer
durable complete response
cytogenetic characteristics
molecular characteristics
trastuzumab

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents