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S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer
NCT00856492 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2010-04 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
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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. It is categorized as Phase 2, 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 215 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT00856492 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Alabama, Arkansas. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00856492?
This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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