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NCT00433511 · ClinicalTrials.gov registry record · 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

A Phase 3 study of Breast Adenocarcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 3
Development phase
4,994
Enrollment target
20
Study locations

NCT00433511 is a Phase 3 study of Breast Adenocarcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 4,994 participants, above the 755-participant average among 18 other Breast Adenocarcinoma trials with a reported enrollment target (561% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT00433511, a Phase 3 study of Breast Adenocarcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
4,994 participants
Enrollment target
20
Study locations

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)

3,257 total trials

What the Registry Record Tells You About NCT00433511

The ClinicalTrials.gov registry entry for NCT00433511 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 4,994 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 755-participant average among 18 other Breast Adenocarcinoma trials with a reported enrollment target (561% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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.

NCT00433511 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Alabama, Alaska.

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.

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).

Who is sponsoring clinical trial NCT00433511?

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

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.

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

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.