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 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT00868634
Eligibility Criteria:
Key Inclusion Criteria:
* Written informed consent.
* Able to comply with the protocol.
* ECOG Performance status 0 - 2.
* Life expectancy more than 12 weeks.
* Known ER / PR status.
* Confirmed HER2/neu-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy.
* Previous (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was applied more than 6 months prior to randomization.
* Previous adjuvant radiotherapy is allowed as part of the treatment of early breast cancer provided that no more than 30% of marrow-bearing bone was irradiated.
* No signs and symptoms of CHF.
* Adequate hepatic and renal function values.
* Adequate hematologic function values.
Key Exclusion Criteria:
* Pregnant or lactating females.
* Previous chemotherapy for metastatic or locally recurrent breast cancer.
* Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain)
* Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases.
* Major surgical procedure, open biopsy or significant traumatic in-jury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment.
* History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
* Uncontrolled hypertension (systolic \> 150 mmHg and/or diastolic \> 100 mmHg). Clinically significant (i.e. active) cardiovascular disease, requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication.
* Non-healing wound, active peptic ulcer or bone fracture.
* History of abdominal fistula, or any grade 4 nongastrointestinal fistula, gastrointestinal perforation or intrabdominal abscess within 6 months of randomization.
* Active infection requiring i.v. antibiotics at randomization.
* Clinically significant malabsorption syndrome or inability to take oral medication.
* Known hypersensitivity to any of the study drugs or excipients.
* Concurrent treatment with any drug interfering with study medication. Concurrent participation in another clinical trial. Prior participation is allowed when the last study medication was applied more than 4 weeks prior to randomization.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00868634
Study Brief:
Protocol Section:
NCT00868634