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ACTIVE NOT RECRUITING
NCT01273610
PHASE2

Tolerability of the Combination of Lapatinib and Trastuzumab in Adults Age 60 or Older With HER2 Positive Locally Advanced or Metastatic Breast Cancer

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

This phase II trial studies the side effects and how well lapatinib ditosylate and trastuzumab work in treating older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or to other parts of the body (metastatic). Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or tumor cancer-killing substances to them. Giving lapatinib ditosylate together with trastuzumab may kill more tumor cells.

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2011-04-20

Completion Date

2026-05-19

Last Updated

2025-06-10

Healthy Volunteers

No

Interventions

DRUG

Lapatinib

250 mg tablets

DRUG

Trastuzumab

Intravenous injection

OTHER

laboratory biomarker analysis

OTHER

pharmacological study

Locations (8)

City of Hope Medical Center

Duarte, California, United States

City of Hope Antelope Valley

Lancaster, California, United States

South Pasadena Cancer Center

Pasadena, California, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Lineberger Comprehensive Cancer Center, University of North Carolina

Chapel Hill, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Case Western Reserve University

Cleveland, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States