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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT00935558
Eligibility Criteria:
Inclusion Criteria:
* Patients with histological proven metastatic or locally advanced ER+/PGR+ breast cancer in progression after receiving 1. line endocrine therapy.
* Further inclusion criteria: p53+ tumour, PS≤1, postmenopausal. Age \>18, PS ≤ 1 and acceptable CBC and blood chemistry results
Exclusion Criteria:
* Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinoma in situ of the cervix and basal/squamous carcinoma of the skin)
* Patients with metastatic disease in the central nervous system
* Patients with other significant illness including severe allergy, asthma, DM, angina pectoris or congestive heart failure
* Patients with acute or chronic infection including HIV, hepatitis og TB
* Patients who received antineoplastic therapy including chemotherapy, radiation, immunotherapy or other agents, less than 4 weeks before the beginning of the trial
* Patients who received corticosteroids or other immunosuppressive agents
* Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis
* Severe hypercalcemia
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00935558
Study Brief:
Protocol Section:
NCT00935558