Capecitabine and Bevacizumab ± Vinorelbine as 1st Line Treatment in HER-2 Negative Metastatic or Locally Advanced Inoperable Breast Cancer Patients
- 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
- 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
- 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
- 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
- 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.