Breast Cancer Study

CALGB 40502: A Randomized Phase III Trial of Weekly Paclitaxel Compared  to Weekly Nanoparticle Albumin Bound Nab-Paclitaxel or Ixabepilone Combined with Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

Protocol ID

08-309

Protocol Description

Paclitaxel is a chemotherapy drug used to treat both advanced and early stage breast cancer. Previous studies have suggested that weekly treatment with paclitaxel might result in a greater likelihood of shrinking the cancer than less frequent treatment with paclitaxel. Paclitaxel blocks the ability of cancer cells to divide and grow, but some cancers are resistant or do not respond to paclitaxel. In addition, paclitaxel is mixed with a solvent that can cause side effects or limit the effectiveness of this drug. This study will compare two newer drugs to paclitaxel: ixabepilone and nab-paclitaxel.

Ixabepilone is a kind of chemotherapy called an epothilone that works in a slightly different way than paclitaxel, and might be able to shrink cancers that are resistant to paclitaxel. Nab-paclitaxel is paclitaxel that is mixed with a protein rather than a solvent, and may also be more effective than paclitaxel. Bevacizumab is a new anti-cancer drug that may slow down the growth of blood vessels to tumors. In a previous clinical trial, the combination of bevacizumab and paclitaxel was more effective at shrinking advanced breast cancer than paclitaxel alone.
The purpose of this study is to compare the anticancer effects and side effects of these three different chemotherapy drugs given on a weekly schedule in combination with bevacizumab.

Eligibility Criteria

Patients with breast cancer

Primary Investigator(s)

  • Daniel Budman, MD

Contact Information

Dolores Weber, RN
(516) 562-8963
dweber@nshs.edu

Last Update

March 26, 2010
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