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:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT00148668
Eligibility Criteria:
Inclusion Criteria:
* Patients with stage II or III breast cancer
* HER-2 positive tumors
* Older than 18 years of age
* Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to 1.
* ANC \> 1,500/mm3
* Hemoglobin \> 9gm/dl
* Platelets \> 100,000mm3
* Creatinine \< 2mg/dl
* Glucose \< 200mg/dl
* Bilirubin \< 1.5 x ULN
Exclusion Criteria:
* Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy.
* Pregnant or breast-feeding women
* Serious illness, or medical or psychiatric condition
* Uncontrolled infections
* Active or severe cardiovascular or pulmonary disease
* Patients with left ventricular ejection fraction \< 50%
* Peripheral neuropathy of any etiology that exceeds grade 1
* Prior history of malignancy
* Uncontrolled diabetes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00148668
Study Brief:
Protocol Section:
NCT00148668