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NCT00312208 · ClinicalTrials.gov registry record · Phase 3

Docetaxel in Breast Cancer

A Phase 3 study of Breast Cancer, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
3,299
Enrollment target
20
Study locations

NCT00312208 is a Phase 3 study of Breast Cancer that has completed, run by Sanofi. The registered enrollment target is 3,299 participants, above the 2,801-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (18% higher). The trial reports 20 study locations across 2 states.

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The verdict

NCT00312208, a Phase 3 study of Breast Cancer, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
3,299 participants
Enrollment target
20
Study locations

Study Summary

Primary objective : * To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive axillary lymph nodes. Secondary objectives : * To compare toxicity and quality of life between the 2 above-mentioned arms. * To evaluate pathologic and molecular markers for predicting efficacy.

Conditions Studied

Interventions

  • DRUG docetaxel, doxorubicin, cyclophosphamide
  • DRUG Docetaxel,doxorubicin, cyclophosphamide

Study Locations (20)

Other

  • Sanofi-Aventis - Buenos Aires
  • Sanofi-Aventis - Macquarie Park
  • Sanofi-Aventis - Brussels
  • Sanofi-Aventis - Sarajevo
  • Sanofi-Aventis - São Paulo
  • Sanofi-Aventis - Sofia
  • Sanofi-Aventis - Laval
  • Sanofi-Aventis - Shanghai
  • Sanofi-Aventis - Bogotá
  • Sanofi-Aventis - Zagreb
  • Sanofi-Aventis - Nicosia
  • Sanofi-Aventis - Prague
  • Sanofi-Aventis - Cairo
  • Sanofi-Aventis - Tallinn
  • Sanofi-Aventis - Paris
  • Sanofi-Aventis - Berlin
  • Sanofi-Aventis - Kallithea
  • Sanofi-Aventis - Hong Kong
  • Sanofi-Aventis - Budapest

New Jersey

  • Sanofi-Aventis - Bridgewater

Trial Details

FieldValue
Enrollment Target 3,299 participants
Start Date 2001-11
Est. Completion 2013-10
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00312208

The ClinicalTrials.gov registry entry for NCT00312208 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,299 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,801-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (18% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which docetaxel, doxorubicin, cyclophosphamide is the first listed.

NCT00312208 reports 20 study locations spanning 2 distinct geographic areas - top geographies include Other, New Jersey.

Frequently Asked Questions

What is clinical trial NCT00312208 about?

NCT00312208 is a clinical study titled "Docetaxel in Breast Cancer". Primary objective : * To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive axillary lymph nodes. Seco...

What is the current status of trial NCT00312208?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,299 participants. The study started on 2001-11. Estimated completion is 2013-10.

What conditions does trial NCT00312208 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00312208?

The interventions under investigation include: docetaxel, doxorubicin, cyclophosphamide (DRUG), Docetaxel,doxorubicin, cyclophosphamide (DRUG).

Who is sponsoring clinical trial NCT00312208?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00312208 being conducted?

This trial has 20 study locations across New Jersey. 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, or report a data error.