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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT05189067
Eligibility Criteria:
Inclusion Criteria:
1. Female aged 18 - 70 years old;
2. The histopathological confirm of invasive breast cancer;
3. HER-2 positive: immuno-histochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) confirmed amplification of erbb2 gene;
4. Tumor must be ≤ 2cm in greatest dimension, negative axillary lymph node or with micrometastasis (axillary nodes with tumor clusters ≤ 0.2cm);
5. No more than 90 days from the patient's most recent breast surgery for this breast cancer;
6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1;
7. Adequate bone marrow function: neutrophil ≥ 1500/mm\^3, hemoglobin ≥ 9 g/dl, and platelets ≥ 100,000/mm\^3;
8. Adequate liver and renal function: creatinine ≤ 1.5 folds of the upper limit of normal value; aspartate aminotransferase and alanine aminotransferase ≤ 1.5 folds of the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2 folds of the upper limit of normal value for patient with Gilbert 's syndrome;
9. Left ventricular ejection fraction (LVEF) ≥ 50%;
10. Willing and able to sign informed consent.
Exclusion Criteria:
1. Any of the following due to teratogenic potential of chemotherapy: pregnant women, nursing women, women of childbearing potential who are unwilling to employ adequate contraception;
2. Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes;
3. History of prior chemotherapy in the past 5 years;
4. History of prior trastuzumab therapy;
5. Patients with a history of previous invasive breast cancer;
6. Active, unresolved infection;
7. Prior history of any other malignancy in the past 5 years, except for early stage tumors of the skin or cervix treated with curative intent;
8. Can not tolerate or be allergic to chemotherapy, anti-HER-2 therapy or pharmaceutical materials such as benzyl alcohol;
9. ≥ grade 2 neuropathy;
10. Active cardiac disease: Any prior myocardial infarction (asymptomatic changes on EKG suggestive of old myocardial infarction is not an exclusion); Documented congestive heart failure (CHF); Current use of any therapy specifically for CHF; Current uncontrolled hypertension (diastolic \>100 mmHg or systolic \> 200 mmHg); Clinically significant pericardial effusion;
11. The antibody of hepatitis C virus, HIV or Treponema pallidum positive; HBsAg positive and hepatitis B virus DNA in peripheral blood ≥ 10\^3 copy/mL；
12. Enrollment on other Investigational studies within 30 days;
13. Not allowed by the investigators.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05189067
Study Brief:
Protocol Section:
NCT05189067