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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT00960960
Eligibility Criteria:
Inclusion Criteria:
* Confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease
* Adequate organ and bone marrow function as assessed by laboratory tests
* Evaluable disease or disease measurable per RECIST
* Agreement to use an effective form of contraception for the duration of the study
Exclusion Criteria:
* History of malabsorption syndrome or other condition that would interfere with enteral absorption
* Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
* Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, radiotherapy, or hormonal therapy) within 4 weeks or 5 half-lives (whichever is shorter) of the first dose of study treatment
* Uncontrolled current illness
* Active small or large intestine inflammation (such as Crohn's disease or ulcerative colitis)
* Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
* Known HIV infection
* New York Heart Association (NYHA) Class II or greater congestive heart failure
* Active ventricular arrhythmia requiring medication
* Pregnancy, lactation, or breastfeeding
* Known significant hypersensitivity to study drugs or excipients
* History of arterial thromboembolic disease within 6 months of first study treatment
* No more than two prior chemotherapy regimens for metastatic disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00960960
Study Brief:
Protocol Section:
NCT00960960