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COMPLETED Phase 3

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

NCT00785291 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Paclitaxel
  • DRUG Nab-paclitaxel
  • BIOLOGICAL Bevacizumab
  • DRUG Ixabepilone

Study Locations (20)

California

  • Kaiser Permanente-Anaheim — Anaheim
  • Kaiser Permanente-Deer Valley Medical Center — Antioch
  • PCR Oncology — Arroyo Grande
  • Kaiser Permanente-Baldwin Park — Baldwin Park
  • Kaiser Permanente-Bellflower — Bellflower
  • Alta Bates Summit Medical Center-Herrick Campus — Berkeley
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank
  • Mills-Peninsula Medical Center — Burlingame
  • East Bay Radiation Oncology Center — Castro Valley
  • Eden Hospital Medical Center — Castro Valley
  • Valley Medical Oncology Consultants-Castro Valley — Castro Valley
  • City of Hope Comprehensive Cancer Center — Duarte
  • Bay Area Breast Surgeons Inc — Emeryville
  • Kaiser Permanente-Fontana — Fontana
  • Kaiser Permanente-Fremont — Fremont
  • Valley Medical Oncology Consultants-Fremont — Fremont

Arkansas

  • Sparks Regional Medical Center — Fort Smith
  • Mercy Hospital Fort Smith — Fort Smith
  • NEA Baptist Memorial Hospital — Jonesboro

Arizona

  • Mayo Clinic in Arizona — Scottsdale

Trial Details

FieldValue
Enrollment Target 799 participants
Start Date 2008-10-13
Est. Completion 2017-06-15
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00785291

The ClinicalTrials.gov registry entry for NCT00785291 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 799 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 9 conditions, with Recurrent Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Laboratory Biomarker Analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00785291 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arkansas, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00785291 about?

NCT00785291 is a clinical study titled "Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer". 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 formulatio...

What is the current status of trial NCT00785291?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 799 participants. The study started on 2008-10-13. Estimated completion is 2017-06-15.

What conditions does trial NCT00785291 study?

This clinical trial studies the following conditions: Recurrent Breast Carcinoma, HER2/Neu Negative, Estrogen Receptor Negative, Progesterone Receptor Negative, Stage IV Breast Cancer AJCC v6 and v7. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00785291?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Nab-paclitaxel (DRUG), Bevacizumab (BIOLOGICAL), Ixabepilone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00785291?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00785291 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial