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NCT00365365 · ClinicalTrials.gov registry record · Phase 2

Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab With or Without Trastuzumab for Adjuvant Treatment of Patients With Breast Cancer

A Phase 2 study, sponsored by Sanofi.

Completed
Registry status
Phase 2
Development phase
214
Enrollment target

NCT00365365 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 214 participants.

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The verdict

NCT00365365, a Phase 2 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 2
Development phase
214 participants
Enrollment target

Study Summary

This is a phase IIb, randomized, parallel-group, noncomparative, multicenter, pilot study designed to evaluate the safety and efficacy of bevacizumab with or without (+/-) trastuzumab administered with three different docetaxel-based combination regimens for the adjuvant treatment of participants with node positive or high-risk node negative breast cancer.

Interventions

  • DRUG Doxorubicin and cyclophosphamide (AC) + bevacizumab
  • DRUG Docetaxel (T) + bevacizumab
  • DRUG Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab
  • DRUG Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab
  • DRUG Bevacizumab and trastuzumab maintenance therapy

Trial Details

FieldValue
Enrollment Target 214 participants
Start Date 2006-08
Est. Completion 2011-10
Phase Phase 2

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00365365

The ClinicalTrials.gov registry entry for NCT00365365 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 214 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Doxorubicin and cyclophosphamide (AC) + bevacizumab is the first listed.

NCT00365365 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00365365 about?

NCT00365365 is a clinical study titled "Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab With or Without Trastuzumab for Adjuvant Treatment of Patients With Breast Cancer". This is a phase IIb, randomized, parallel-group, noncomparative, multicenter, pilot study designed to evaluate the safety and efficacy of bevacizumab with or without (+/-) trastuzumab administered with three different docetaxel-based combination regimens for the adjuvant treatment of participants wi...

What is the current status of trial NCT00365365?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 214 participants. The study started on 2006-08. Estimated completion is 2011-10.

What interventions are being tested in trial NCT00365365?

The interventions under investigation include: Doxorubicin and cyclophosphamide (AC) + bevacizumab (DRUG), Docetaxel (T) + bevacizumab (DRUG), Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab (DRUG), Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab (DRUG), Bevacizumab and trastuzumab maintenance therapy (DRUG).

Who is sponsoring clinical trial NCT00365365?

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

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.