Study:
A 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
Rationale:
Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and
paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can
block tumor growth in different ways. Some block the ability of tumor cells to grow and
spread. Others find tumor cells and help kill them or carry tumor-killing substances to
them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the
tumor. Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells
that remain after surgery. It is not yet known whether doxorubicin, cyclophosphamide, and
paclitaxel are more effective with or without bevacizumab in treating breast cancer.
Purpose:
This randomized phase III trial is studying doxorubicin, cyclophosphamide, and paclitaxel to
see how well they work with or without bevacizumab in treating patients with lymph
node-positive or high-risk, lymph node-negative breast cancer. Drugs used in chemotherapy,
such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some
block the ability of tumor cells to grow and spread. Others find tumor cells and help kill
them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of
breast cancer by blocking blood flow to the tumor. Giving chemotherapy together with
bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet
known whether doxorubicin, cyclophosphamide, and paclitaxel are more effective with or
without bevacizumab in treating breast cancer.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Male Breast Cancer
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer |
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: paclitaxel
Biological: bevacizumab
Other: placebo |
Phase 3 |
Verified by
National Cancer Institute (NCI)
April, 2013
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00433511
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Florida - Weston
Weston, Florida 33331
United States
Kathy Miller., Principal Investigator