Paclitaxel Plus Bevacizumab for Older Patients With Breast Cancer

Hellenic Oncology Research Group

Status and phase

Terminated

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Paclitaxel

Drug: Bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT01120158

CT/08.31

Details and patient eligibility

About

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.

Full description

Elderly individuals make up a large part of the breast cancer population. Older women are more likely than younger women to be diagnosed at a more advanced stage of breast cancer. However, when treated with chemotherapy for metastatic disease they derive similar benefits to their younger counterparts. Preference should be given to chemotherapeutic drugs with safer profiles regimens, such as weekly taxane, according to the SIOG recommendations. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone

Enrollment

46 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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