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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT01402193
Eligibility Criteria:
Inclusion Criteria:
* Provision of informed consent
* Pathological confirmation of breast cancer
* ER(+) and/or PR(+).
* Post-menopausal woman
* Age≤70 years old
* Breast conservative surgery with axillary dissection or staging by either sentinel nodes biopsy or axillary sampling
* Post-mastectomy patients with T1-T2 and N1-N3, or T3-T4 with any N Negative surgical margins
* Karnofsky≥70
* Laboratory criteria:
* PLT≥100\*109/L
* WBC≥4000/mm3
* HGB≥10g/dl
* ALT and AST\<2\*ULN
* No presence of metastatic disease
* No other malignant tumour
Exclusion Criteria:
* Presence of metastatic disease.
* T1, T2, N0 with mastectomy
* Non-infiltrative breast carcinoma underwent mastectomy
* Other malignant tumor (concurrent or previous).
* Positive surgical margins.
* Patients with demonstrated hypersensitivity to Arimidex or any excipient.
* Patients with severe renal impairment (creatinine clearance less than 20 ml/min).
* Patients with moderate or severe hepatic disease.
* Oestrogen-containing therapies should not be co-administered with Arimidex as they would negate its pharmacological action.
* Not able or willing to sign informed consent
* Autoimmune diseases including scleroderma, systemic lupus erythematosus and so on
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01402193
Study Brief:
Protocol Section:
NCT01402193