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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT01314833
Eligibility Criteria:
Inclusion Criteria:
* Female patients, age at diagnosis 18 - 75 years
* Histological confirmed unilateral primary invasive carcinoma of the breast
* Adequate surgical treatment with complete resection of the tumor (R0) and resection of \> or = 10 axillary nodes or SLN in clinically N0 patients
* Node positive disease or node-negative disease with at least one other risk factor (tumor size \> or = 2 cm, grade \> or = II)
* HER2-negative disease
* No evidence for distant metastasis (M0) after conventional staging
* Performance Status ECOG \< or = 1
* The patient must be accessible for treatment and follow-up
* LVEF\> 50%
* Negative pregnancy test (urine or serum) within 7 days prior to randomization in premenopausal patients
* Leucocytes \> or = 4 x 10\^9/L
* platelets \> or = 100 x 10\^9/L
* haemoglobin \> or = 9 g/dL
* total bilirubin \< or = 1.5 UNL
* ASAT (SGOT) and ALAT (SGPT) \< or = 2.5 UNL
* creatinine \< 175 mmol/L (2 mg/dL)
Exclusion Criteria:
1. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy）;
2. Has bilateral breast cancer;
3. Has the previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
4. Has metastatic (Stage 4) breast cancer;
5. Has any \>T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer);
6. Is pregnant, is breastfeeding women, or women of childbearing age who cannot practice effective contraceptives;
7. Patients participating in other clinical trials at the same time;
8. Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \< 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
9. Has known allergy to taxane and excipients;
10. Has severe or uncontrolled infection.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01314833
Study Brief:
Protocol Section:
NCT01314833