Phase II clinical study of bevacizumab in combination with capecitabine as first-line treatment in elderly patients with metastatic breast cancer

SOUTH EASTERN EUROPEAN RESEARCH ONCOLOGY GROUP0 sites88 target enrollmentOctober 14, 2009

ConditionsMetastatic or locally recurrent HER2-negative breast cancer MedDRA version: 12.0Level: LLTClassification code 10055113Term: Breast cancer metastatic MedDRA version: 12.0Level: LLTClassification code 10006198Term: Breast cancer recurrent

DrugsAVASTIN®XELODA®

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metastatic or locally recurrent HER2-negative breast cancer
Sponsor: SOUTH EASTERN EUROPEAN RESEARCH ONCOLOGY GROUP
Enrollment: 88
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 14, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

SOUTH EASTERN EUROPEAN RESEARCH ONCOLOGY GROUP

Eligibility Criteria

Inclusion Criteria

•To be eligible for the study, each patient must fulfil all of the following inclusion criteria:
•1\.Signed informed consent obtained prior to initiation of any study specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with the study requirements;
•2\.Age \= 70 years;
•3\.Pathologically confirmed and documented metastatic breast cancer or locally recurrent breast cancer not amenable to curative treatment. Complete radiology and tumor measurement workup must be completed within 4 weeks prior to first study treatment;
•4\.Measurable disease according to RECIST criteria;
•5\.HER2 negative disease;
•6\.No prior treatment for metastatic or locally recurrent disease;
•7\.Prior radiotherapy is allowed if delivered at least 2 weeks before enrolment in the study and for the relief of metastatic bone pain, and provided that no more than 30% of marrow\-bearing bone was irradiated and that target lesions were not included in the radiotherapy field;
•8\.Not suitable for aggressive chemotherapy regimen in the opinion of the investigator;
•9\.Performance status ECOG 0 – 2\.

Exclusion Criteria

•1\.Any prior neoadjuvant or adjuvant treatment with anthracyclines completed less than 6 months prior to enrolment. The maximum cumulative dose received must not have exceeded 360 mg/m2 for doxorubicin or 720 mg/m2 for epirubicin. Prior anti\-epidermal growth factor therapy is allowed;
•2\.Concurrent hormonal therapy; however previous hormonal therapy is allowed for adjuvant, locally recurrent, or metastatic breast cancer if completed within \=1 months prior to enrollment;
•3\.History or clinical evidence of brain metastases. If there is any clinical suspicion of brain metastasis, a computerized tomography (CT) scan or magnetic resonance imaging (MRI) of the brain must be conducted within 4 weeks prior to enrolment;
•4\.Other malignancy (including primary brain tumors) within the last 5 years, which could affect the diagnosis or assessment of breast cancer, except for adequately treated carcinoma in situ of the cervix, squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer;
•5\.Life expectancy \< 12 weeks;
•6\.Any of the following abnormal values:
•Inadequate bone marrow function: hemoglobin (Hb) \< 8\.0 g/dL, absolute neutrophil count (ANC) \< 1\.5 x 109/L, or platelet count \< 100 x 109/L;Inadequate liver function: AST/SGOT or ALT/SGPT \> 2\.5 x upper limit of normal (ULN) or \> 5 x ULN in patients with liver metastases), serum alkaline phosphatase \> 2\.5 ULN or \> 5 x ULN in patients with liver metastases, or \> 10 x ULN in patients with bone metastases or total bilirubin \> 2 x ULN; Moderate or severe renal impairment: creatinine clearance \= 50 mL/min (calculated according to the Cockroft and Gault formula; see Appendix 1\), or serum creatinine \> 1\.5 x ULN;
•7\.Chronic daily treatment with aspirin (\> 325 mg/day) or clopidogrel (\> 75 mg / day);
•8\.Chronic daily treatment with corticosteroids (dose of \> 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids);
•9\.Requirement for concurrent use of the antiviral agents sorivudine or brivudine;