Lapatinib Ditosylate and Radiation Therapy in Treating Patients With Locally Advanced or Locally Recurrent Breast Cancer

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT01868503
Phase
PHASE2
Status
Terminated

Conditions

  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer

Eligibility Criteria

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

Interventions

  • lapatinib ditosylate — DRUG
    Given PO
  • radiation therapy — RADIATION
    Undergo radiation therapy
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase II trial studies how well lapatinib ditosylate and radiation therapy work in treating patients with locally advanced or locally recurrent breast cancer. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving lapatinib ditosylate together with radiation therapy may be an effective treatment for breast cancer.

Key Dates

Start date
Jul 31, 2013
Status verified
Jun 2017
Primary completion
Dec 31, 2014
Completion
Jul 31, 2015

Study Design

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

Arms

  • Experimental: Lapatinib Plus Radiation Therapy
    Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks and will have their blood banked for laboratory biomarker analysis.

Primary Outcome Measure

Percentage of Patients Achieving Complete Clinical Response [ Time Frame: Up to 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University Cancer InstituteStanfordCalifornia94305-

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