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 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT01722968
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-70 years.
2. Performance status ECOG 0-2.
3. Clinically and / or radiologically proven stage IV or recurrent HER2 negative breast cancer.
4. At least one tumor lesion accessible for biopsy. This lesion may not have been treated previously with irradiation.
5. Clinically and/or radiographically documented measurable disease according to RECIST v1.1 criteria. At least one site of disease must be unidimensionally measurable as follows:
1. CT-scan, physical exam ≥ 10 mm} Chest X-ray ≥ 20 mm }see Eisenhauer et al. for more details
2. Lymph node short axis ≥ 15 mm }
3. All radiology studies must be performed within 28 days prior to registration (35 days if negative).
6. Adequate bone-marrow, hepatic and renal function defined as laboratory tests within 7 days prior to enrollment:
1. Haematology: Absolute granulocytes \> 1.5 x 109/L Platelets \> 100 x 109/L
2. Biochemistry:Bilirubin within normal limits Serum creatinine within normal limits
7. APTT and INR within normal limits within 7 days prior to enrollment.
8. Adequate cardiac function with Left Ventricular Ejection Fraction (LVEF) within normal limits determined by echocardiogram or MUGA within 28 days prior to inclusion.
9. Written informed consent must be given.
Exclusion Criteria:
1. Previous systemic treatment for MBC.
2. Major surgery less than 28 days prior to enrollment.
3. Concurrent malignancy of any site, except adequately controlled limited basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix.
4. Bleeding diathesis, history of thromboembolic disease, or ongoing treatment with warfarin, heparin analogs or antiplatelet drugs.
5. Major cardiac comorbidity.
6. Previous treatment with bevacizumab.
7. Previous allergic reaction to taxane analogs.
8. Ongoing pregnancy or lactation.
9. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01722968
Study Brief:
Protocol Section:
NCT01722968