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NCT00856492 · ClinicalTrials.gov registry record · Phase 2

S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer

A Phase 2 study of Breast Cancer, sponsored by SWOG Cancer Research Network.

Completed
Registry status
Phase 2
Development phase
215
Enrollment target
20
Study locations

NCT00856492: Completed Phase 2 study of Breast Cancer, sponsored by SWOG Cancer Research Network.

NCT00856492 is a Phase 2 study of Breast Cancer that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 215 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00856492, a Phase 2 study of Breast Cancer, has completed, sponsored by SWOG Cancer Research Network.

COMPLETED
Registry status
Phase 2
Development phase
215 participants
Enrollment target
20
Study locations

Study Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which treatment regimen is more effective in treating women with breast cancer. PURPOSE: This randomized phase II trial is studying paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin, cyclophosphamide, and pegfilgrastim to compare how well they work when given with or without bevacizumab in treating women with inflammatory or locally advanced breast cancer.

Conditions Studied

Breast Cancer

Interventions

  • DRUG cyclophosphamide
  • DRUG paclitaxel albumin-stabilized nanoparticle formulation
  • BIOLOGICAL bevacizumab
  • DRUG doxorubicin hydrochloride
  • BIOLOGICAL pegfilgrastim

Study Locations (20)

California

  • Alta Bates Summit Comprehensive Cancer Center - Berkeley
  • Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center - Burbank
  • Peninsula Medical Center - Burlingame
  • East Bay Radiation Oncology Center - Castro Valley
  • Valley Medical Oncology Consultants - Castro Valley - Castro Valley
  • Valley Medical Oncology - Fremont
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center - Loma Linda
  • Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center - Long Beach
  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center - Los Angeles
  • USC/Norris Comprehensive Cancer Center and Hospital - Los Angeles
  • Contra Costa Regional Medical Center - Martinez
  • Tibotec Therapeutics - Division of Ortho Biotech Products, LP - Marysville
  • El Camino Hospital Cancer Center - Mountain View
  • Sutter Health - Western Division Cancer Research Group - Novato
  • Highland General Hospital - Oakland
  • Alta Bates Summit Medical Center - Summit Campus - Oakland
  • Bay Area Breast Surgeons, Incorporated - Oakland
  • CCOP - Bay Area Tumor Institute - Oakland

Alabama

  • Providence Cancer Center at Providence Hospital - Mobile

Arkansas

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences - Little Rock

Trial Details

FieldValue
Enrollment Target 215 participants
Start Date 2010-04
Est. Completion 2015-12
Phase Phase 2

Sponsor

SWOG Cancer Research Network

270 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00856492

The ClinicalTrials.gov registry entry for NCT00856492 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (92% lower). The listed sponsor is SWOG Cancer Research Network, which has 270 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.

NCT00856492 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Alabama, Arkansas.

Frequently Asked Questions

What is clinical trial NCT00856492 about?

NCT00856492 is a clinical study titled "S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfi...

What is the current status of trial NCT00856492?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 215 participants. The study started on 2010-04. Estimated completion is 2015-12.

What conditions does trial NCT00856492 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00856492?

The interventions under investigation include: cyclophosphamide (DRUG), paclitaxel albumin-stabilized nanoparticle formulation (DRUG), bevacizumab (BIOLOGICAL), doxorubicin hydrochloride (DRUG), pegfilgrastim (BIOLOGICAL).

Who is sponsoring clinical trial NCT00856492?

This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00856492 being conducted?

This trial has 20 study locations across Alabama, 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, the data changelog, or report a data error.