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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT00258960
Eligibility Criteria:
Inclusion Criteria:
* Patients must sign an informed consent before of specific procedures of clinical trial.
* Patients with histologically confirmed breast cancer and overexpression of Her2neu.
* Age\> 18 years.
* Eastern Cooperative Oncology Group (ECOG) equal or \< 2.
* Patients have not been treated previously with chemotherapy for metastatic disease.
* Patients must have at least one measurable lesion according to RECIST criteria.
* Patients should have an adequate organ function to tolerate chemotherapy.
Exclusion Criteria:
* Patients with hypersensitivity reactions to any of the medications of the clinical trial.
* Patients who are pregnant or lactating are not eligible.
* Hepatic disease.
* Not controlled active infection
* Symptomatic metastatic brain cancer
* Previous adjuvant treatment with anthracyclines with a total accumulated dose \> 300 mg/m2 (Doxorubicin) or \> 600 mg/m2 (Epirubicin)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00258960
Study Brief:
Protocol Section:
NCT00258960