Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT01875367
Eligibility Criteria:
Inclusion Criteria:
* Woman, 18 years old or upper.
* Patient with advanced breast cancer with human epidermal growth factor receptor 2 (HER 2) positive histologically confirmed. The criteria for positivity HER 2 are:
1. immuno-histochemistry (IHC) 3+ (\>10% of tumor cells with complete and intense membrane staining)
2. IHC 2+ with fluorescent in situ hybridization (FISH) / Chromogenic in situ hybridization (CISH) / silver-enhanced in situ hybridization (SISH) + for HER 2 amplification (\*)
3. FISH / CISH / SISH + for HER 2 amplification (\*) (\*) Defined as the ratio of copies of HER 2/neu and copies of centromere of chromosome 17 (CEP17)\> 2.2, or a number of copies of HER 2/neu\> 6, as per local laboratory criteria.
* Patient receiving trastuzumab with or without chemotherapy or hormonal therapy for at least 4 months.
* No evidence of disease progression (clinical and / or radiological) for at least 4 months before inclusion in the study and with a life expectancy of at least 3 months.
* Adequate performance status: Eastern Cooperative Oncology Group (ECOG) \<2.
* Adequate bone marrow function, liver and kidney
* Proper cardiac function (LVEF within normal limits the center, measured by echocardiography or MUGA).
* The patient must have been informed of the study and must sign and date informed consent document for entry into the trial.
* The patient must be willing and able to comply with study procedures and be available to answer the study questionnaires.
Exclusion Criteria:
* Patients with no advanced breast cancer.
* Breast cancer patients with tumors HER 2-negative.
* The patient has another active malignancy other than breast adenocarcinoma; are excluded the non-melanoma skin cancer or any other properly treated in situ neoplasia. Patients with a history of malignancy, if they bear\> 5 years without evidence of disease could be included.
* The patient has uncontrolled brain metastases.
* Concomitant administration, or in the 4 weeks prior to study entry, of other experimental treatment.
* Known hypersensitivity to trastuzumab or to any of its components.
* Patients with severe dyspnea at rest or requiring supplemental oxygen.
* Heart disease or serious medical pathological prevent trastuzumab administration: documented history of congestive cardiac insufficiency (CCI), high-risk arrhythmias uncontrolled angina requiring medication, clinically significant valvular disease, history of myocardial infarction or evidence of transmural infarction on ECG or hypertension poorly controlled.
* Presence of any concomitant serious systemic disease that is incompatible with the study (at the discretion of the investigator).
* The patient is pregnant or lactating. Women of childbearing potential should undergo pregnancy testing blood or urine within 14 days prior to inclusion as institutional rules and use a non-hormonal contraceptive suitable: intrauterine device, barrier method (condom or diaphragm) also used in conjunction with spermicidal cream, total abstinence or surgical sterilization, during treatment with the study drugs and for 6 months following the end of treatment.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01875367
Study Brief:
Protocol Section:
NCT01875367