Lapatinib With Trastuzumab in Treating Patients With HER2-Negative/HER2 Mutant Metastatic Breast Cancer

Sponsor
Washington University School of Medicine
Study ID
NCT01557764
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lapatinib ditosylate — DRUG
    Given PO
  • trastuzumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial studies the effectiveness of lapatinib ditosylate (lapatinib) together with trastuzumab in treating patients with HER2-negative breast cancer that carries HER2 gene mutations. Lapatinib may kill tumor cells by blocking some of the enzymes needed for cell division and growth. Trastuzumab, a monoclonal antibody, may block the ability of tumor cells to grow and spread. Giving lapatinib together with trastuzumab may provide a more effective treatment for patients with this type of cancer.

Key Dates

Start date
Sep 30, 2012
Status verified
Jul 2013
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (enzyme inhibitor and monoclonal antibody)
    Patients receive lapatinib PO QD on days 1-21 and trastuzumab IV over 90 minutes on day 1 of a 21-day cycle. Treatment continues in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall clinical benefit rate (CBR; CD + PR + SD) of lapatinib and trastuzumab in patients with breast cancer that carry HER2 mutations [ Time Frame: 6 months ]

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