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NCT00436566 · ClinicalTrials.gov registry record · Phase 2

Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery

A Phase 2 study, sponsored by Mayo Clinic.

Completed
Registry status
Phase 2
Development phase
122
Enrollment target

NCT00436566: Completed Phase 2 study, sponsored by Mayo Clinic.

NCT00436566 is a Phase 2 study that has completed, run by Mayo Clinic. The registered enrollment target is 122 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00436566, a Phase 2 study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 2
Development phase
122 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, 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. Giving combination chemotherapy together with trastuzumab and lapatinib after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized phase II trial is studying the side effects and how well giving doxorubicin together with cyclophosphamide followed by trastuzumab, paclitaxel, and lapatinib works in treating patients with early-stage HER2-positive breast cancer that has been removed by surgery.

Interventions

  • DRUG cyclophosphamide
  • DRUG paclitaxel
  • BIOLOGICAL trastuzumab
  • DRUG doxorubicin hydrochloride
  • DRUG lapatinib ditosylate

Trial Details

FieldValue
Enrollment Target 122 participants
Start Date 2007-03-16
Est. Completion 2019-07-22
Phase Phase 2

Sponsor

Mayo Clinic

2,844 total trials

What the Registry Record Tells You About NCT00436566

The ClinicalTrials.gov registry entry for NCT00436566 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.

NCT00436566 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00436566 about?

NCT00436566 is a clinical study titled "Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery". RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, 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....

What is the current status of trial NCT00436566?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 122 participants. The study started on 2007-03-16. Estimated completion is 2019-07-22.

What interventions are being tested in trial NCT00436566?

The interventions under investigation include: cyclophosphamide (DRUG), paclitaxel (DRUG), trastuzumab (BIOLOGICAL), doxorubicin hydrochloride (DRUG), lapatinib ditosylate (DRUG).

Who is sponsoring clinical trial NCT00436566?

This trial is sponsored by Mayo Clinic, which has 2,844 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, the data changelog, or report a data error.