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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT01654367
Eligibility Criteria:
Inclusion Criteria:
1. Karnofsky≥70
2. Provision of informed consent
3. Pathological confirmation of breast cancer
4. Hormone receptor-positive and accept aromatase inhibitors for adjuvant endocrine therapy
5. Not previously received treatment with bisphosphonate
6. Laboratory criteria:
PLT≥100\*109/L WBC≥4000/mm3 HGB≥10g/dl GOT,GPT,ALP≤2\*ULN TBIL,DBIL,CCr≤1.5\*ULN
7. Surgery , radiotherapy and chemotherapy has finished
Exclusion Criteria:
1. Pregnant of lactation woman
2. History of organ transplantation
3. With mental disease
4. With severe infection or active gastrointestinal ulcers
5. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
6. Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ)
7. With heart disease
8. Experimental drug allergy
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT01654367
Study Brief:
Protocol Section:
NCT01654367