Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer

Conditions

• Estrogen Receptor Negative
• Estrogen Receptor Positive
• HER2/Neu Negative
• HER2/Neu Positive
• Progesterone Receptor Negative
• Progesterone Receptor Positive
• Recurrent Breast Carcinoma
• Stage IIIC Breast Cancer AJCC v6
• Stage IV Breast Cancer AJCC v6 and v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Ixabepilone — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Nab-paclitaxel — DRUG
  Given IV
• Paclitaxel — DRUG
  Given IV
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

This randomized phase III trial studies the side effects and how well different chemotherapy regimens with or without bevacizumab work in treating patients with stage IIIC or stage IV breast cancer. Drugs used in chemotherapy, such as paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel), and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may block tumor growth by targeting certain cells and slowing the growth of blood vessels to the tumor. It is not yet known which treatment regimen is more effective in treating patients with breast cancer.

Key Dates

First listed

Nov 5, 2008

Start date

Oct 13, 2008

Status verified

May 2026

Primary completion

Dec 31, 2013

Completion

Jun 15, 2017

Study Design

Enrollment

799 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (Paclitaxel)
  Patients receive 90 mg/m\^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15.
• Experimental: Arm B (Nab-paclitaxel)
  Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15.
• Experimental: Arm C (Ixabepilone)
  Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. (closed to accrual as of 7/18/11)

Primary Outcome Measure

Progression Free Survival [ Time Frame: Time from randomization to progression or death due to any cause, whichever occurs first (up to 5 years) ]

Locations (703)

Find similar trials in Scottsdale, AZ

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