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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT00493350
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed invasive breast cancer. Patients must have clinical and/or radiologic evidence of stage IV disease. Tumor may be of any hormone receptor type.
* Patients must have newly diagnosed stage IV breast cancer that is scheduled to start a new systemic therapy.
* Patients may have measurable or non-measurable disease.
* Extent of disease will be determined by physical examination and imaging studies as per the primary physician. The tests utilized may include: (bone scans, PET/CT scans, CT of the abdomen, chest radiograph and/or CT of the chest for visceral metastases, sonogram and/or MRI for soft tissue disease). Patients with skin lesions will have photographs to evaluate their lesions.
* ECOG performance status 0-2.
* Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policies of the hospital. The only acceptable consent form is the one attached at the end of this protocol.
Exclusion Criteria:
* Patients with evidence of local regional recurrence only are excluded.
* Patients who have received prior therapy for their metastatic breast disease.
* Patients with known evidence of brain metastases (unless previously treated or stable) or carcinomatous meningitis.
* Patients with history of any prior malignancies that have not been disease-free for at least 5 years prior to study entry.
* Patients unwilling or unable to give consent.
* Patients unwilling or unable to provided follow-up on their condition.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00493350
Study Brief:
Protocol Section:
NCT00493350