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NCT00769470 · ClinicalTrials.gov registry record · Phase 2

Docetaxel, Carboplatin, and Trastuzumab and/or Lapatinib in Treating Women With Stage I, Stage II, or Stage III Breast Cancer That Can Be Removed by Surgery

A Phase 2 study of Breast Cancer, sponsored by Translational Oncology Research International.

Completed
Registry status
Phase 2
Development phase
18
Enrollment target
15
Study locations

NCT00769470 is a Phase 2 study of Breast Cancer that has completed, run by Translational Oncology Research International. The registered enrollment target is 18 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 15 study locations across 5 states.

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The verdict

NCT00769470, a Phase 2 study of Breast Cancer, has completed, sponsored by Translational Oncology Research International.

COMPLETED
Registry status
Phase 2
Development phase
18 participants
Enrollment target
15
Study locations

Study Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether docetaxel and carboplatin are more effective when given together with trastuzumab and/or lapatinib in treating women with stage I, stage II, or stage III breast cancer. PURPOSE: This randomized phase II trial is studying how well docetaxel and carboplatin work when given together with trastuzumab and/or lapatinib in treating women with stage I, stage II, or stage III breast cancer that can be removed by surgery.

Conditions Studied

Interventions

  • DRUG carboplatin
  • DRUG docetaxel
  • BIOLOGICAL trastuzumab
  • DRUG lapatinib ditosylate

Study Locations (15)

California

  • Central Hematology Oncology Medical Group, Incorporated - Alhambra - Alhambra
  • Comprehensive Blood and Cancer Center - Bakersfield
  • St. Jude Heritage Medical Group at Virginia K. Crosson Cancer Center - Fullerton
  • North Valley Hematology-Oncology Medical Group - Northridge
  • Wilshire Oncology Medical Group, Incorporated - Pomona - Pomona
  • Sansum Medical Clinic - Santa Barbara
  • Central Coast Medical Oncology Corporation - Santa Maria
  • Santa Barbara Hematology Oncology - Solvang - Solvang
  • Cancer Care Associates Medical Group, Incorporated - Redondo Beach - Torrance

Florida

  • Cancer Institute of Florida, PA - Orlando - Orlando
  • Florida Hospital Cancer Institute - Orlando
  • Hematology and Oncology Consultants, PA - Orlando - Orlando

Indiana

  • Providence Medical Group - Haute Terre

Nevada

  • Comprehensive Cancer Centers of Nevada - Henderson - Henderson

New Mexico

  • New Mexico Cancer Center - Albuquerque

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2009-04
Phase Phase 2

What the Registry Record Tells You About NCT00769470

The ClinicalTrials.gov registry entry for NCT00769470 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Translational Oncology Research International, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which carboplatin is the first listed.

NCT00769470 reports 15 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Indiana.

Frequently Asked Questions

What is clinical trial NCT00769470 about?

NCT00769470 is a clinical study titled "Docetaxel, Carboplatin, and Trastuzumab and/or Lapatinib in Treating Women With Stage I, Stage II, or Stage III Breast Cancer That Can Be Removed by Surgery". RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the abil...

What is the current status of trial NCT00769470?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2009-04.

What conditions does trial NCT00769470 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00769470?

The interventions under investigation include: carboplatin (DRUG), docetaxel (DRUG), trastuzumab (BIOLOGICAL), lapatinib ditosylate (DRUG).

Who is sponsoring clinical trial NCT00769470?

This trial is sponsored by Translational Oncology Research International, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00769470 being conducted?

This trial has 15 study locations across California, Florida, Indiana, Nevada, New Mexico. 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.