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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT01378533
Eligibility Criteria:
Inclusion Criteria:
1. Patient must accept the modified radical mastectomy
2. Patients with histologically confirmed ER(-) PR(-) and HER-2(-)
3. Positive axillary lymph nodes;negative axillary lymph node with age\< 35 years or Ⅲ grade or intravascular cancer embolus.
4. Age between 18 years to 65 years
5. Able to give informed consent
6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
7. Not pregnant, and on appropriate birth control if of child-bearing potential.
8. Adequate bone marrow reserve with ANC \> 1000 and platelets \> 100,000.
9. Adequate renal function with serum creatinine \< 2.0.
10. Adequate hepatic reserve with serum bilirubin \< 2.0, AST/ALT \< 2X the upper limit of normal, and alkaline phosphatase \< 5X the upper limit of normal. Serum bilirubin \> 2.0 is acceptable in the setting of known Gilbert's syndrome.
11. No active major medical or psychosocial problems that could be complicated by study participation.
Exclusion Criteria:
1. received neo-adjuvant therapy
2. Cardiac dysfunction documented by an ejection fraction less than the lower limit of the facility normal by multi-gated acquisition (MUGA) scan, or 45% by echocardiogram. -The rate of Disease recurrence
3. Uncontrolled medical problems.
4. Evidence of active acute or chronic infection.
5. Pregnant or breast feeding.
6. Hepatic, renal, or bone marrow dysfunction as detailed above.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01378533
Study Brief:
Protocol Section:
NCT01378533