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:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT01116869
Eligibility Criteria:
Inclusion Criteria
* Female
* over 18 and less than 70 years of age
* Subject having agreed to participate in the study and follow the study procedures by providing written informed consent prior entering the study.
* For MBC Subject Set only Confirmed metastatic breast cancer patient with at least one measurable solid tumor according to the RECIST guideline Starting a new line of systemic therapy which is recommended in the Chinese edition of NCCN Clinical Practice Guidelines in Oncology Breast Cancer Guideline 2009 line of chemotherapy should be over 3 ECOG performance grade of 0 to 2 Life expectancy over 3 months
* For Healthy Subject Set only Medical examinations detect no breast benign and malignant tumors
* For Benign Breast Disease Subject Set only Pathology diagnosed breast benign tumor disease
Exclusion Criteria
* Self reported pregnancy
* For MBC Subject Set only Prior history of other malignancy Patients who have surgery to remove any metastatic lesions or receive radiation therapy during her participation in the study
* For Healthy Subject Set only Prior history of breast benign tumor disease or any malignancy Any conditions inappropriate for blood drawing
* For Benign Breast Disease Subject Set only Prior history of any malignancy Any conditions inappropriate for blood drawing
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01116869
Study Brief:
Protocol Section:
NCT01116869