Paclitaxel Plus Bevacizumab for Older Patients With Breast Cancer

• Status: Terminated
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will evaluate the efficacy, safety and effect on quality of life of weekly paclitaxel plus bevacizumab as first line treatment in elderly patients (≥ 70 years old) with metastatic breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the functional status of patients according to the comprehensive geriatric assessment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic breast adenocarcinoma

• No previous therapy (other than hormonal therapy) for metastatic disease is accepted

• Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)

• Performance status (WHO) 0-2

• Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases)

• adequate renal function (serum creatinine <1.5 times the upper normal limit)

• bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)

• No radiation of measurable disease (except brain metastases)

• No progressive brain metastases according to clinical or radiological criteria

• No brain metastases without prior radiation therapy

• Written informed consent

Exclusion Criteria:

• Active infection

• History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)

• History of stroke

• Anticoagulation therapy (except of low dose aspirin <325mg)

• Other invasive malignancy except non-melanoma skin cancer

• Psychiatric illness or social situation that would preclude study compliance

• Pregnant or lactating women