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

Completed · Phase 3

Conditions studied: 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

In brief

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 facts

Study ID

NCT00785291

Run by

National Cancer Institute (NCI)

People needed

799

Starts

2008-10-13

Expected to finish

2017-06-15

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic confirmation of invasive cancer of the breast
• Stage IV disease or stage IIIC disease (using American Joint Committee on Cancer [AJCC] criteria, 6th edition) not amenable to local therapy
• Patients may not have a "currently active" second malignancy other than non-melanoma skin cancers; patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse
• Patients with human epidermal growth factor receptor 2 (HER2) negative disease are eligible; patients with HER2+ disease are eligible providing they have previously received trastuzumab or lapatinib; documentation of progression on HER2 directed therapy is not required; Her2/neu status must be known at the time of protocol registration
• Estrogen receptor (ER) and progesterone receptor (PgR) status must be known at the time of registration; ER and/or PgR >= 1% cells will be considered positive
• Prior treatment may include adjuvant or neoadjuvant taxane, however, the interval between completion of adjuvant or neoadjuvant therapy and disease recurrence must be >= 12 months
• No prior chemotherapy for metastatic breast cancer
• Any number of prior hormonal therapies are allowed; the last dose should have been administered at least 7 days prior to the initiation of protocol therapy
• Prior radiotherapy must be completed at least 2 weeks prior to study entry
• Treatment with bisphosphonates is allowed and recommended as per American Society of Clinical Oncology (ASCO) guidelines
• Prior trastuzumab or lapatinib required for patients with HER2 overexpressing tumors
• Prior treatment with bevacizumab is allowed
• Patients must not have had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study registration, and must have fully recovered from any such procedure
• The following are not considered to be major procedures: thoracentesis, paracentesis, port placement, laparoscopy, thoracoscopy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies and routine dental procedures
• Patients must not have anticipation of need for a major surgical procedure during the course of the study
• There are no restrictions on core biopsies, placement of a vascular access device or other minor procedures prior to registration
• Placement of a vascular access device after starting study therapy should be performed between day 15 and 28 of a treatment cycle (but not less than 48 hours before the next dose of bevacizumab) to allow for sufficient healing
• Patients must have measurable disease (target lesions): measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2.0 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan
• Lesions that are considered non-measurable include the following:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural/pericardial effusion
• Inflammatory breast disease
• Lymphangitis cutis/pulmonitis

Where it is running

• Sparks Regional Medical Center — Fort Smith, Arkansas, United States
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
• NEA Baptist Memorial Hospital — Jonesboro, Arkansas, United States
• Kaiser Permanente-Anaheim — Anaheim, California, United States
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
• PCR Oncology — Arroyo Grande, California, United States
• Kaiser Permanente-Baldwin Park — Baldwin Park, California, United States
• Kaiser Permanente-Bellflower — Bellflower, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Mills-Peninsula Medical Center — Burlingame, California, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Bay Area Breast Surgeons Inc — Emeryville, California, United States
• Kaiser Permanente-Fontana — Fontana, California, United States
• Kaiser Permanente-Fremont — Fremont, California, United States
• Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
• Kaiser Permanente-Fresno — Fresno, California, United States
• Marin Cancer Care Inc — Greenbrae, California, United States
• Marin General Hospital — Greenbrae, California, United States
• Kaiser Permanente - Harbor City — Harbor City, California, United States
• Kaiser Permanente-Irvine — Irvine, California, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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