NCT01120158

Paclitaxel Plus Bevacizumab for Older Patients With Breast Cancer

Biweekly Paclitaxel Plus Bevacizumab as First Line Treatment for Older Patients With Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	Bevacizumab (IV) 10 mg/kg on day 1 and day 15. Treatment repeats every 28 days. Therapy will continue until maximum response, disease progression or unacceptable toxicity.
DRUG	Paclitaxel	Paclitaxel (IV) 120 mg/m2,on day 1 and day 15. Treatment repeats every 28 days Therapy will continue until maximum response, disease progression or unacceptable toxicity.

Timeline

• Start date: 2009-09-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2010-05-10
• Last updated: 2017-02-23

Locations

11 sites across 1 country: Greece