A randomized phase III clinical study of bevacizumab plus capecitabine vs. bevacizumab alone as maintenance therapy in patients with HER2-negative metastatic breast cancer that has not progressed during first-line docetaxel plus bevacizumab therapy. - IMELDA

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 420

Inclusion Criteria

Initial treatment phase: 1. Signed informed consent obtained prior to initiation of any study specific procedures or treatment as confirmation of the patients awareness and willingness to comply with the study requirements 2. Age ≥ 18 years 3. Patients with histologically confirmed and documented, HER2-negative metastatic adenocarcinoma of the breast, who are candidates for taxane-based chemotherapy 4. Documented ER/PgR status 5. ECOG PS of 0-1; 6. Life expectancy of ≥ 12 weeks
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

1. Previous chemotherapy for mBC. Prior hormone therapy for metastatic disease is allowed. 2. Prior adjuvant/neoadjuvant chemotherapy within 6 m. prior to first study treatment administration. 3. Prior adjuvant/neoadjuvant anthracycline-based chemotherapy with a max. cumulative dose >360 mg/m2 for doxorubicin or >720 mg/m2 for epirubicin. 4. Prior radiotherapy for the treatment of metastatic disease. Radiotherapy administered for the relief of metastatic bone pain is allowed prior to study entry, as long as no more than 30% of marrow-bearing bone was irradiated. 5. Chronic daily treatment with aspirin (>325 mg/day) or clopidogrel (>75 mg/day). 6. Requirement for concurrent use of the antiviral agent sorivudine, or chemically related analogues, such as brivudine. 7. Chronic daily treatment with corticosteroids (dose of ≥10 mg/day methylprednisolone or equivalent), with the exception of inhaled steroids. 8. Current or recent treatment with another investigational drug or participation in another investigational study. 9. Inadequate bone marrow function: ANC: <1.5 x 10E9/l, platelet count <100 x 10E9/l or haemoglobin <8 g/dl. 10. Inadequate liver function, defined as: serum (total) bilirubin >1.5 x ULN for the institution AST/SGOT or ALT/SGPT >2.5 x ULN (>5 x ULN in patients with liver metastases) ALP >2.5 x ULN at baseline (>5 x ULN in patients with liver metastases, or >10 x ULN in patients with bone metastases). 11. Inadequate renal function, defined as: serum creatinine >1.5 x ULN creatinine clearance <50 ml/min (calculated according to Cockroft and Gault) urine dipstick for proteinuria >2+. Patients with ≥2+ proteinuria on dipstick analysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤1g of protein in the 24-hour urine. 12. Patients not receiving anticoagulant medication who have an INR >1.5 or an aPTT >1.5 x ULN within 7 days prior to first study treatment. Note: Patients receiving full dose oral or parenteral anticoagulants may be included in the study as long as anticoagulant dosing has been stable for at least two weeks prior to study entry and the appropriate coagulation monitoring tests are within local therapeutic limits. 13. Evidence of spinal cord compression or brain metastases. 14. Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. 15. Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. 16. Women of childbearing potential (defined as <2 years after last menstruation and not surgically sterile) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly). Et al.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials