Viewing Study NCT00378638



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Study NCT ID: NCT00378638
Status: UNKNOWN
Last Update Posted: 2007-10-24
First Post: 2006-09-18

Brief Title: Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymph Node Positive Breast Cancer A Pilot Study
Sponsor: Chap Linnea I MD
Organization: Chap Linnea I MD

Study Overview

Official Title: Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymp Node Positive Breast Cancer A Pilot Study
Status: UNKNOWN
Status Verified Date: 2007-10
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This research focuses on women with breast cancer whose disease has not significantly progressed but who have 5 or more lymph nodes involved In this study subjects will receive bevacizumab a drug which is FDA approved for colon cancer but not for breast cancer in combination with a regimen of approved chemotherapy drugs known as dose dense chemotherapy The study will observe the effectiveness and tolerability of this regimen
Detailed Description: Approximately 200000 women are diagnosed with breast cancer in the United States every year A significant factor determining long-term survivability of breast cancer is whether or not lymph nodes glands which cleanse and filter the bodys fluids are involved Despite treatment with approved multiagent cytotoxic chemotherapy dose-dense chemotherapy women with breast cancer involving more than 4 axillary lymph nodes still have a high risk for recurrence

Several dose-dense chemotherapy regimens are currently being compared in other studies however at this time there is no proof that one regimen is superior to another Therefore in an attempt to decrease metastases prolong time to recurrence and improve overall survival it is essential to develop novel therapeutic strategies The use of inhibitors of angiogenesis represents a promising option

Bevacizumab is the first angiogenesis inhibiting drug to be FDA approved for the treatment of colon cancer It is has also been studied alone in progressed lymph-node positive breast cancer and has shown moderate efficacy

This study will observe the efficacy and tolerability of using bevacizumab in combination with an approved dose-dense chemotherapy regimen for 8 cycles followed by 12 of bevacizumab alone Patients may be on the study for up to 52 weeks if their disease has not progressed and the regimen is tolerated

Study Oversight

Has Oversight DMC: None
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?: None