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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT01159405
Eligibility Criteria:
Inclusion Criteria:
* Patients with newly diagnosed stage I-IV breast cancer (tumor size
* 2cm in imaging examinations) who are scheduled to start systemic therapy.
* Patients must have histological diagnosis of invasive breast cancer.
* Extent of disease will be determined by physical examination and conventional radiological studies.
* Must be age 18 or older.
* ECOG performance status 0-2.
* Patients with history of prior malignancies must be disease-free for at least 5 years of study entry.
* Normal hematological function: WBC \> 3000/ul, absolute neutrophil count \> 1500/ul, platelets \> 100,000/ul, and Hgb \> 10 gms (transfusion to achieve Hgb \> 10 gms is acceptable).
* Serum total bilirubin \< 1.5 mg/dl and SGPT \< 1.5 X normal.
* Adequate kidney function (creatinine \< 1.5 mg/dL).
Exclusion Criteria:
* Patients who received previous chemotherapy for the newly diagnosed breast cancer.
* No evidence of primary breast lesion (e.g. T0, Tx).
* Pregnant women or sexually active women of childbearing potential who are not practicing adequate contraception are excluded.
* Patients with myocardial infarction within 6 months of study entry; unstable angina pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmia are excluded.
* Patients with history of hypersensitivity/allergy to Chitosan/Chitin related shellfish foods.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01159405
Study Brief:
Protocol Section:
NCT01159405