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A Phase III Trial of Paclitaxel versus Nanoparticle Albumin-Bound Paclitaxel or Ixabepilone plus Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

[Protocol 09-100]

Full Title :
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 (CALGB 40502/CTSU 40502)(VERSION DATE 09/04/08)
Purpose :

Paclitaxel is 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 cancer than less frequent treatment with paclitaxel. Paclitaxel blocks the ability of cancer cells to divide and grow, but some cancers do not respond to this drug. In addition, paclitaxel is mixed with a solvent that can cause side effects or limit its effectiveness.

This study will compare two newer drugs to paclitaxel -- ixabepilone and nanoparticle albumin-bound (NAB)-paclitaxel -- in patients with locally recurrent or metastatic breast cancer. Ixabepilone is an epothilone drug that works in a slightly different way than paclitaxel, and might be able to shrink cancers that no longer respond to paclitaxel. NAB-paclitaxel consists of paclitaxel mixed with a protein, and may be more effective than paclitaxel.

Patients in this study will be randomly assigned to receive paclitaxel, NAB-paclitaxel, or ixabepilone. All patients will also receive bevacizumab, which interferes with the development of the blood vessels tumors need to grow and spread. The effectiveness of the three regimens will be compared.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage IIIB or IV breast cancer that has not yet been treated with chemotherapy.
  • Patients must have recovered from the side effects of prior therapies.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Diana Lake at 646-888-5444.

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