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:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
NCT ID:
NCT00503906
Eligibility Criteria:
Inclusion Criteria
1. Patients must either be:
* treatment-naïve with newly diagnosed her2neu non-overexpressing (non amplified) metastatic (Stage IV) breast cancer, or
* HER2/neu-negative patients with metastasis diagnosed 6 or more months after completing primary systemic treatment (neoadjuvant, adjuvant chemotherapy).
2. No previous chemotherapy regimen for metastatic breast cancer.
3. 18 years of age or older.
4. Measurable disease as defined by RECIST criteria or evaluable disease.
5. Eastern Cooperative Oncology Group (ECOG) 0-1.
6. Life expectancy greater than 3 months.
7. For female (or male) patients, either pre- or post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study
8. Provide written informed consent before any study-related procedure not part of normal medical care is conducted
9. Willing and able to comply with the protocol requirement
10. Laboratory parameters as follows:
* Neutrophils: 1.5 x109/L or greater
* Platelets: 100 x109/L or greater
* Hemoglobin: ≥ 9.0 g/dL
* Serum Creatinine: ≤ 1.5mg/dL
* Bilirubin: ≤ ULN, except when caused by metastatic disease
* Alanine transaminase (ALT)/Aspartate transaminase (AST): ≤ 2.5 times the upper limit of the normal range (ULN) except when caused by metastatic disease
* Urine protein creatinine (UPC) ratio \< 1.0 at screening.
Exclusion Criteria
1. Previous treatment with gemcitabine.
2. History of Gastrointestinal Bleeding in the previous 3 months.
3. Chemotherapy within 4 weeks prior to enrollment.
4. Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.
5. Any major surgery within 4 weeks prior to enrollment.
6. Presence of central nervous system or brain metastases.
7. Urine protein: creatinine ratio ≥ 1.0 at screening.
8. Inadequately controlled hypertension (defined as systolic blood pressure \> 150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications).
9. A prior history of hypertensive crisis or hypertensive encephalopathy.
10. Peripheral neuropathy \> grade I.
11. Clinical AIDS or known positive HIV serology
12. No concurrent clinically evident malignancy is allowed except inactive non-melanoma skin cancer and inactive cervical cancer diagnosed or other cancer for which the patient has been disease-free for five years.
13. Unstable angina.
14. New York Heart Association (NYHA) Grade II or greater congestive heart failure
15. History of myocardial infarction within 6 months.
16. History of stroke within 6 months.
17. Clinically significant peripheral vascular disease.
18. Evidence of bleeding diathesis or coagulopathy
19. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, anticipation of need for major surgical procedure during the course of the study.
20. Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to enrollment.
21. Pregnant (positive pregnancy test) or lactating.
22. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment
23. Serious, non-healing wound, ulcer, or bone fracture
24. Inability to comply with study and/or follow-up procedures
25. Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible.
26. Participants cannot have been in another experimental drug study other than a Bevacizumab cancer study within 4 weeks of the first infusion of these study medications.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00503906
Study Brief:
Protocol Section:
NCT00503906