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

NCT00118157 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-12-04

Study results available
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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.

Conditions

  • Estrogen Receptor Positive
  • Male Breast Carcinoma
  • Progesterone Receptor Positive
  • Recurrent Breast Carcinoma
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Lapatinib Ditosylate

Given PO

DRUG

Tamoxifen Citrate

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Elaina Gartner · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2011-07-31
Completion
2014-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00118157 on ClinicalTrials.gov