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 Group1 site in 1 country88 target enrollmentMay 2010

ConditionsBreast Cancer Metastasis

DrugsCapecitabine and Bevacizumab

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: South Eastern European Research Oncology Group
Enrollment: 88
Locations: 1
Primary Endpoint: Time to treatment progression
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, single-arm, multicenter study of capecitabine and bevacizumab administered as first-line treatment of previously untreated elderly patients, older than 70 years, with metastatic or locally recurrent breast cancer.

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

August 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

South Eastern European Research Oncology Group

Eligibility Criteria

Inclusion Criteria

•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 Protocol code: ML22373 Protocol SEEROG: version 1.
•Date: October 15, 2009 3 study requirements;
•Age ≥70 years;
•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;
•Measurable disease according to RECIST criteria;
•HER2 negative disease;
•No prior treatment for metastatic or locally recurrent disease;
•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;
•Not suitable for aggressive chemotherapy regimen in the opinion of the investigator;
•Performance status ECOG 0 - 2.

Exclusion Criteria

•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;
•Concurrent hormonal therapy; however previous hormonal therapy is allowed for adjuvant, locally recurrent, or metastatic breast cancer if completed within ≥1 months prior to enrolment;
•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;
•Other malignancy (including primary brain tumors) within the Protocol code: ML22373 Protocol SEEROG: version 1.
•Date: October 15, 2009 4 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;
•Life expectancy \< 12 weeks;
•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 cockcroft and Gault formula; see Appendix 1), or serum creatinine \> 1.5 x ULN;

Outcomes

Primary Outcomes

Time to treatment progression

Time Frame: average 5 years

followed until death

Secondary Outcomes

overall response rate in patients with measurable disease at baseline(average 5 years)
safety and tolerability(average 5 years)
Clinical benefit (complete response, partial response and stable disease) in patients with measurable disease at baseline(average 5 years)
progression-free survival(average 5 years)