Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer

NCT00433511 · View on ClinicalTrials.gov ↗

Study Summary

This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, 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. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery and help prevent the tumor from returning. It is not yet known whether doxorubicin hydrochloride, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab.

Conditions Studied

Interventions

  • DRUG Cyclophosphamide
  • OTHER Laboratory Biomarker Analysis
  • DRUG Paclitaxel
  • DRUG Doxorubicin Hydrochloride
  • BIOLOGICAL Bevacizumab

Study Locations (20)

California

  • Kaiser Permanente-Deer Valley Medical Center — Antioch
  • PCR Oncology — Arroyo Grande
  • 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
  • Bay Area Breast Surgeons Inc — Emeryville
  • Kaiser Permanente-Fremont — Fremont
  • Valley Medical Oncology Consultants-Fremont — Fremont

Alabama

  • Northeast Alabama Regional Medical Center — Anniston
  • University of Alabama at Birmingham Cancer Center — Birmingham
  • Providence Hospital — Mobile

Alaska

  • Alaska Regional Hospital — Anchorage
  • Providence Alaska Medical Center — Anchorage

Arizona

  • Virginia G Piper Cancer Care-Del Camino — Scottsdale
  • Mayo Clinic in Arizona — Scottsdale

Arkansas

  • Mercy Hospital Fort Smith — Fort Smith
  • University of Arkansas for Medical Sciences — Little Rock

Trial Details

FieldValue
Enrollment Target 4,994 participants
Start Date 2007-11-02
Est. Completion 2026-02-22
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

2,390 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00433511

The ClinicalTrials.gov registry entry for NCT00433511 describes a study currently listed as active not recruiting. 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 4,994 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 1 condition, with Breast Adenocarcinoma 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: NCT00433511 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Alabama, Alaska. 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 NCT00433511 about?

NCT00433511 is a clinical study titled "Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer". This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is ...

What is the current status of trial NCT00433511?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 4,994 participants. The study started on 2007-11-02. Estimated completion is 2026-02-22.

What conditions does trial NCT00433511 study?

This clinical trial studies the following conditions: Breast Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00433511?

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

Who is sponsoring clinical trial NCT00433511?

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 NCT00433511 being conducted?

This trial has 20 study locations across Alabama, Alaska, 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