Doxorubicin, cyclophosphamide, and paclitaxel with or without bevacizumab in treating patients with lymph node-positive or high-risk, lymph node-negative breast cancer

eagle-i ID

Resource Type

Properties

1. ClinicalTrials.gov url

   http://www.clinicaltrials.gov/ct2/show/NCT00433511?term=E5103&rank=1

2. Intervention

   Bevacizumab

3. Additional Topic(s)

   Antineoplastic combined chemotherapy

4. Resource Description

   The purpose of this study is to determine if adding a medication by the name of bevacizumab to the current standard chemotherapy of cancer-reducing medications, namely doxorubicin, cyclophosphamide and paclitaxel, reduces the risk of recurrence (called disease-free survival) compared to standard chemotherapy alone. Bevacizumab has been approved by the FDA (Food and Drug Administration) for use in the chemotherapy treatment of patients with colorectal cancer. The outcome for those patients showed improvement with the use of this drug. In this study, Bevacizumab is considered investigational because it has not received FDA approval as yet for use in breast cancer. However, this drug has been extensively studied in previous breast cancer clinical trials. These studies showed improved results in patients whose breast cancer recurred. Based on these results, it is hoped that using this medication or this type of medication earlier in treatment of the disease may lead to better outcomes for this group of patients.

5. Additional Name

   Double-blind phase III trial of doxorubicin and cyclophosphamide followed by paclitaxel with bevacizumab or placebo in patients with lymph node positive and high risk lymph node negative breast cancer

6. Contact

   Berenberg, Jeffrey

7. PI

   Berenberg, Jeffrey

8. Topic

   breast cancer

9. Study Population

   Men and women 18 years of age and over with histologically confirmed adenocarcinoma of the breast at risk for distant recurrence.

10. Website(s)

    http://www.cancer.gov/clinicaltrials/search/view?cdrid=528955&version=healthprofessional

11. Funded by

    Cancer Trials Support Unit

12. Phase

    Phase 3 clinical trial

13. Performed by

    Clinical Protocol & Data Management Shared Resource