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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT01273610
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Lapatinib — DRUG
    250 mg tablets
  • Trastuzumab — DRUG
    Intravenous injection
  • laboratory biomarker analysis — OTHER
  • pharmacological study — OTHER

Study Details

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 Dates

Start date
Apr 20, 2011
Status verified
May 2025
Primary completion
Feb 22, 2018
Completion
May 19, 2026

Study Design

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

Arms

  • Experimental: Lapatinib and trastuzumab
    Patients receive lapatinib ditosylate PO QD and trastuzumab IV once weekly OR once every 3 weeks. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Percent of Participants With Grade 3 or Higher Non-hematological Toxicities and Symptomatic Congestive Heart Failure [ Time Frame: Until 30 days after last dose of treatment, an average of 8 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
City of Hope Antelope ValleyLancasterCalifornia93534-
South Pasadena Cancer CenterPasadenaCalifornia91030-
Roswell Park Cancer InstituteBuffaloNew York14263-
Lineberger Comprehensive Cancer Center, University of North CarolinaChapel HillNorth Carolina27599-
Duke University Medical CenterDurhamNorth Carolina27704-
Case Western Reserve UniversityClevelandOhio44106-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Find similar trials in Duarte, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
City of Hope Medical Center· Duarte, CACity of Hope Antelope Valley· Lancaster, CASouth Pasadena Cancer Center· Pasadena, CARoswell Park Cancer Institute· Buffalo, NYLineberger Comprehensive Cancer Center, University of North Carolina· Chapel Hill, NCDuke University Medical Center· Durham, NC

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