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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT00870168
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the breast
* Metastatic disease
* No inflammatory breast cancer
* Measurable disease according to RECIST criteria
* Hormone receptor status:
* Estrogen receptor- and/or progesterone receptor-negative by IHC
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* WHO performance status 0-2
* Life expectancy \> 3 months
* ANC \> 1.5 x 10\^9/L
* Platelet count \> 100 x 10\^9/L
* Liver transaminases ≤ 3 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3 times ULN
* Bilirubin ≤ 1.5 times ULN
* Creatinine ≤ 2 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No allergy to xylocaine
* No heart failure, or kidney, bone marrow, respiratory, or liver insufficiency
PRIOR CONCURRENT THERAPY:
* No prior first-line treatment for metastatic disease
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00870168
Study Brief:
Protocol Section:
NCT00870168