CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Lapatinib Ditosylate +2 moredrug
Likely dose
Lapatinib ditosylate given orally in combination with tamoxifen citrate given orally (specific doses not detailed in arms/interventions)AI-extracted
Key inclusion· 7
  • ✓Primary adenocarcinoma of the breast confirmed histologically or cytologically
  • ✓Locally advanced or metastatic disease not amenable to curative surgery or radiation
  • ✓Estrogen and/or progesterone receptor positive cancer
  • ✓Failed tamoxifen as single agent (primary resistance or secondary failure)
Key exclusion· 7
  • ✕Prior EGFR or HER2-targeting therapies (prior adjuvant trastuzumab with chemotherapy only allowed, but trastuzumab with hormonal therapy excluded)
  • ✕Current anti-neoplastic therapy other than zoledronic acid for bone metastases/hypercalcemia
  • ✕Rapidly progressive disease (lymphangitic spread, bulky liver metastases) or brain/leptomeningeal metastases requiring active therapy
  • ✕Major cardiac event within 6 months (MI, severe angina, CHF, CVA, TIA, CABG/PBAG)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00118157
NCT00118157Phase 2Completed
CompareCT.gov

A Phase II Study of GW572016 and Tamoxifen in Patients With Metastatic Breast Cancer Resistant to Single-Agent Tamoxifen

National Cancer Institute (NCI)·interventional·Posted Jul 11, 2005·Updated Dec 4, 2017

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Lapatinib Ditosylate, and 1 other intervention for Estrogen Receptor Positive and 6 related conditions. Completed, enrolled 19 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEstrogen Receptor Positive, Male Breast Carcinoma, Progesterone Receptor Positive, Recurrent Breast Carcinoma, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 11, 2005
Enrollment StartMay 1, 2005
Primary CompletionJul 1, 2011
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 21.0 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Lapatinib Ditosylatedrug

Given PO

Tamoxifen Citratedrug

Given PO