locally recurrent or metastatic breast cancer MedDRA version: 9.1 Level: LLT Classification code 10006198 Term: Breast cancer recurrent MedDRA version: 9.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer
Conditions
Interventions
Trade Name: Avastin
Product Name: Avastin
Pharmaceutical Form: Intravenous infusion
Trade Name: Xeloda
Product Name: Xeloda
Pharmaceutical Form: Tablet
Trade Name: Taxol
Product Name: paclitaxel
Pro
Sponsors
VU Medisch Centrum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with histologically or cytologically confirmed, HER2/neu-negative, pre- or postmenopausal adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to resection and/or radiotherapy with curative intent. - Documented ER/PR status - HER2/neu-negative disease as determined by immunohistochemistry or FISH/CISH - Prior adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was not within 6 months (not within 12 months if taxane-based) prior to randomization. - Prior maximum cumulative dose must not exceed 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin - Female only - Age ? 18 years and = 75 years - ECOG PS of 0 or 1 - Life expectancy of ? 12 weeks - Able to comply with the protocol - Written informed consent (Informed Consent document to be approved by the institution’s Independent Ethics Committee [IEC]) obtained prior to any study specific screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previous chemotherapy for locally recurrent or metastatic breast cancer • Prior hormonal therapy for locally recurrent or metastatic disease should have been discontinued at least 2 weeks before randomization. • Patients with bone metastases only are allowed provided that they are on bisphosphonate treatment > 3 months. - Patients who have received adjuvant radiotherapy as part of the treatment of early breast cancer are eligible if the last fraction of radiotherapy was administered at least 6 months prior to randomization. Radiotherapy administered for the relief of metastatic bone pain is allowed prior to study entry, but • no more than 30% of marrow-bearing bone should have been irradiated • the last fraction of radiotherapy should not have been administered within 3 weeks prior to randomization. - Other primary tumors within the last 5 years before inclusion, except for adequately controlled basal cell carcinoma of the skin, or carcinoma in situ of the cervix - Previous or current CNS metastases. A CT or MRI of the brain must be performed within 4 weeks prior to randomization if the presence of metastases at this site is suspected. - Inadequate bone marrow function: ANC: < 1.5 x 109/L, platelet count < 100 x 109/L and hemoglobin < 6 mmol/L. - Inadequate liver function. - History or evidence or inherited bleeding diathesis or coagulopathy with the risk of bleeding - History of cerebrovascular accident - Arterial or venous thrombosis = 12 months prior to registration - Uncontrolled hypertension or clinically significant cardiovascular disease. - Inadequate left ventricular ejection fraction at baseline. - Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate Progression Free Survival (PFS) in patients randomized to: - bevacizumab 10 mg/kg q2wk + paclitaxel 90 mg/m2 on days 1, 8 and 15 of a 4-week cycle versus - bevacizumab 15 mg/kg day 1 + paclitaxel 90 mg/m2 on days 1 and 8 + capecitabine 825 mg/m2 orally twice daily on days 1-14 of a 3-week cycle ;Secondary Objective: To determine: - Overall RR, duration of response and overall survival - Safety ;Primary end point(s): Progression Free Survival | — |
Countries
Netherlands
Outcome results
None listed