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NCT00118157 · ClinicalTrials.gov registry record · Phase 2

Lapatinib and Tamoxifen in Treating Patients With Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Previous Tamoxifen

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
19
Enrollment target

NCT00118157: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00118157 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00118157, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
19 participants
Enrollment target

Study Summary

This phase II trial studies how well giving lapatinib ditosylate together with tamoxifen citrate works in treating patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes or to other areas of the body and did not respond to previous treatment with tamoxifen citrate. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Sometimes when tamoxifen citrate is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to tamoxifen citrate. Giving lapatinib ditosylate together with tamoxifen citrate may reduce drug resistance and allow the tumor cells to be killed.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Tamoxifen Citrate
  • DRUG Lapatinib Ditosylate

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2005-05
Est. Completion 2014-09
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00118157

The ClinicalTrials.gov registry entry for NCT00118157 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT00118157 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00118157 about?

NCT00118157 is a clinical study titled "Lapatinib and Tamoxifen in Treating Patients With Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Previous Tamoxifen". This phase II trial studies how well giving lapatinib ditosylate together with tamoxifen citrate works in treating patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes or to other areas of the body and did not respond to previous treatment with tamoxifen ...

What is the current status of trial NCT00118157?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2005-05. Estimated completion is 2014-09.

What interventions are being tested in trial NCT00118157?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Tamoxifen Citrate (DRUG), Lapatinib Ditosylate (DRUG).

Who is sponsoring clinical trial NCT00118157?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 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.