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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT01203267
Eligibility Criteria:
Inclusion Criteria:
* Women aged ≥ 18 years and \< 70 years
* Karnofsky performance status (KPS) ≥ 70
* At least one measurable disease according to the RECIST. histologically confirmed invasive breast cancer (excluding inflammatory breast cancer), large operable (T≥3 cm and N0-1) or locally advanced breast cancer (T3-4N0-3 or T0-4N2-3)
* Biopsy specimens are available for ER, PgR and Her2 analysis
* Adequate bone marrow function: Neutrophil ≥ 1.5\*109/L; Hb ≥ 100g/L; PLT ≥ 100\*109/L
* An estimated life expectancy of at least 12 months
* Willing to take biopsy before neoadjuvant chemotherapy and patients must be accessible for treatment and follow-up
* Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
* Written informed consent according to the GCP
Exclusion Criteria:
* Prior systemic or loco-regional treatment of breast cancer, including chemotherapy
* Metastatic breast cancer
* With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
* Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
* inadequate liver function (bilirubin \> 1.0 times upper normal limit \[UNL\] and ALT and/or AST\> 1.5 UNL associated with alkaline phosphatase \> 2.5 UNL; inadequate renal function (creatinine \> 1.0 times UNL and in case of limit value, Creatinine clearance \< 60 ml/min)
* Contraindication for using dexamethasone
* History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP \> 180 mmHg or diastolic BP \> 100 mmHg)
* Has peripheral neuropathy ≥ grade 1
* Patient is pregnant or breast feeding
* Known severe hypersensitivity to any drugs in this study
* Treatment with any investigational drugs within 30 days before the beginning of study treatment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01203267
Study Brief:
Protocol Section:
NCT01203267