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NCT00785291 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Recurrent Breast Carcinoma and HER2/Neu Negative, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 3
Development phase
799
Enrollment target
20
Study locations

NCT00785291 is a Phase 3 study of Recurrent Breast Carcinoma and HER2/Neu Negative that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 799 participants, above the 263-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (204% higher). The trial reports 20 study locations across 3 states.

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The verdict

NCT00785291, a Phase 3 study of Recurrent Breast Carcinoma and HER2/Neu Negative, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 3
Development phase
799 participants
Enrollment target
20
Study locations

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)

3,257 total trials

What the Registry Record Tells You About NCT00785291

The ClinicalTrials.gov registry entry for NCT00785291 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 799 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 263-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (204% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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.

NCT00785291 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arkansas, Arizona.

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.

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).

Who is sponsoring clinical trial NCT00785291?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.