Viewing Study NCT01120158


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Study NCT ID: NCT01120158
Status: TERMINATED
Last Update Posted: 2017-02-23
First Post: 2010-05-05
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Paclitaxel Plus Bevacizumab for Older Patients With Breast Cancer
Sponsor: Hellenic Oncology Research Group
Organization:

Study Overview

Official Title: Biweekly Paclitaxel Plus Bevacizumab as First Line Treatment for Older Patients With Metastatic Breast Cancer
Status: TERMINATED
Status Verified Date: 2017-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Due to poor accrual
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: