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 — DRUGGiven PO
- radiation therapy — RADIATIONUndergo radiation therapy
- laboratory biomarker analysis — OTHERCorrelative 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 TherapyPatients 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stanford University Cancer Institute | Stanford | California | 94305 | - |
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