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NCT00076024 · ClinicalTrials.gov registry record · Phase 1

AG-013736 In Combination With Docetaxel Versus Docetaxel Alone For Patients With Metastatic Breast Cancer

A Phase 1 study of Breast Neoplasms, sponsored by Pfizer.

Completed
Registry status
Phase 1
Development phase
174
Enrollment target
20
Study locations

NCT00076024: Completed Phase 1 study of Breast Neoplasms, sponsored by Pfizer.

NCT00076024 is a Phase 1 study of Breast Neoplasms that has completed, run by Pfizer. The registered enrollment target is 174 participants, below the 567-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00076024, a Phase 1 study of Breast Neoplasms, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 1
Development phase
174 participants
Enrollment target
20
Study locations

Study Summary

The primary purpose of the study is to determine the time to progression of the combination of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of study drug that can be given with docetaxel administered on an every 3 week schedule.

Primary Outcome

Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]).

Conditions Studied

Breast Neoplasms

Interventions

  • DRUG Placebo
  • DRUG Docetaxel
  • DRUG AG-013736 (axitinib)

Study Locations (20)

Florida

  • Pfizer Investigational Site - Jacksonville
  • Pfizer Investigational Site - Jacksonville
  • Pfizer Investigational Site - Jacksonville
  • Pfizer Investigational Site - Jacksonville Beach
  • Pfizer Investigational Site - Melbourne
  • Pfizer Investigational Site - Orange Park
  • Pfizer Investigational Site - Palatka
  • Pfizer Investigational Site - Saint Augustine

California

  • Pfizer Investigational Site - Berkeley
  • Pfizer Investigational Site - Montebello
  • Pfizer Investigational Site - Monterey Park
  • Pfizer Investigational Site - San Francisco
  • Pfizer Investigational Site - San Gabriel
  • Pfizer Investigational Site - Whittier

Illinois

  • Pfizer Investigational Site - Chicago
  • Pfizer Investigational Site - Chicago
  • Pfizer Investigational Site - Zion

Arizona

  • Pfizer Investigational Site - Tucson
  • Pfizer Investigational Site - Tucson

Massachusetts

  • Pfizer Investigational Site - Boston

Trial Details

FieldValue
Enrollment Target 174 participants
Start Date 2004-02
Est. Completion 2008-11
Phase Phase 1
Pfizer

1,845 total trials

What the finished NCT00076024 record still lists

NCT00076024 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 567-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (69% lower).

The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00076024 names 20 study sites across 5 states, led by Florida, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT00076024 about?

NCT00076024 is a clinical study titled "AG-013736 In Combination With Docetaxel Versus Docetaxel Alone For Patients With Metastatic Breast Cancer". The primary purpose of the study is to determine the time to progression of the combination of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of...

What is the current status of trial NCT00076024?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 174 participants. The study started on 2004-02. Estimated completion is 2008-11.

What conditions does trial NCT00076024 study?

This clinical trial studies the following conditions: Breast Neoplasms.

What interventions are being tested in trial NCT00076024?

The interventions under investigation include: Placebo (DRUG), Docetaxel (DRUG), AG-013736 (axitinib) (DRUG).

Who is sponsoring clinical trial NCT00076024?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00076024 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Breast Neoplasms

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00076024's enrollment target sits among peer trials

174 42nd of 97 higher than 56 of 97 other Breast Neoplasms trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00076024, the US trial registry maintained by the National Library of Medicine. NCT00076024 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.